The Amazing Bremelanotide PT-141 (Vyleesi)

This post was updated 5JUL19, when I received word that the FDA approved Bremelanotide PT-141 under the name Vylessi. I updated this post, and subsequently added the name Vylessi to all mention of Bremelanotide PT-141, and added updated histories and commentaries at the end.

We have a tendency to think inside the box. We try to improve what we know. We try to work within the framework of what we have. We actually do need to think "outside the box"...

As a man gets older, your body changes. Your hair starts receding, and starts to fall out. You start to become bald. Your hair turns white. Your teeth start giving you problems, and you start to gain weight. Getting rid of that weight becomes problematic. No longer can exercise alone keep you trim and fit. You have to change your diet as well.

All men eventually start to have erectile disfunction (ED). Usually it seems to start in your early 40’s depending on your stress level, lifestyle, and general health. You can postpone it for a few years, but it will eventually strike. It will.

Typically, erectile disfunction more closely resembles a moderate soft erection. This is due to the blood pressure in the penis. As a man gets older, his ability to create solid rock-hard erections diminishes. Instead, when excited he produces short-lived soft and “spongy” erections, often cycling between a moderate “soft” erection and no erection at all.

This is what it is like to grow old.

Now, you can exercise. You can eat special foods, and you can have a stress-free life that can all significantly reduce these effects. For instance, leeks and eggs, bitter melon and oysters can certainly help the man in the bedroom. It will do wonders, as will a daily glass of red wine…

Enter Viagra

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Who hasn’t heard of this “miracle” pill?

Viagra entered the world in the 1990’s and revitalized the world of the American male. No longer did older men need to live a sex-less life. All you need do is pop in a “little blue pill” and all your troubles are over.

Of course, there are some tradeoffs.

For one, you need to get a doctors’ prescription. America is just about the ONLY nation that has this bastardized restriction. Everyone can just get the medicine off the shelf just about anywhere. Secondly, you have to pay REAL money for it. In a world where the raw material of Viagra (sildenafil) costs $100 / kg, and where a single dosage of Viagra is 25mg, the price difference is astounding.

It costs ten cents a gram for sildenafil, or ten cents for 1000mg. That’s ten cents for 40 pills. But Big American Pharmacies and their associated industries are charging an insane amount for this pill.

The cost for Viagra oral tablet 25 mg is around $447 for a supply of 6 tablets, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
-Drugs.com

It’s a good thing that I live in China, where I can get a bag of 100 generic pills for under $1.20.

Ah, but I digress…

"Abroad, getting Viagra is no problem as it is readily available over the counter in many countries. In countries I’ve been to, it sells for $1 a pill. Then, it’s party on. No such luck in the police state known as America. Got to have a doctor’s prescription, and it’s pricey. But, it’s worth it for the occasional twosome or threesome when there’s blow involved."

-If you are going to use Cocaine use Viagra

Enter Cialis

While it is certainly convenient, the problem with Viagra is that it tends to give you a headache, and does not mix well with alcohol. Which really sucks as most of us older folk prefer to drink and have fun, often leading up to a sexual romp or two.

And then came Cialis…

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You take a Cialis pill on a Friday, and you are good to go up until next Tuesday. That’s four days, boys and girls. OK, well, three days of erection when you want it, and as long lasting as you need it. Four days it begins to sputter out. It’s erection on demand, and they are of high quality and long duration. Perfect for cuddling with that special person in your life. The real problem with this is that it takes around three hours to work, so it doesn’t lend itself to spontaneous sexual encounters.

It is ideal for a married man who wants to spend quality time with his wife.

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Cialis is not licensed in China, so the only way you can get it at a pharmacy is to pay “full price”. Which is often 120 RMB/pill, or roughly $20/pill. That in itself pretty much sucks. Salaries in China are far below the salaries in the United States, so when you spend $20, it’s like spending enough to cover a weeks amount of food.

But then again, you can simply buy the (Tadalafil) powder here. Weigh it out. Mix it up yourself and use it.

I understand that a generic version is available in the UK, which would be a good alternative if you didn’t want to have a closet full of 500,000 Cialis pills lying around after your mix up your own batch. (BTW, India doesn’t really care about these licensed patents, and makes the pills anyways. Licensing and FDA be damned. So you can get great quality Cialis Generic out of India for maybe a fraction of the cost for what you would pay in the USA.)

It’s worth it, you know. You can spend quality time and focus on the time together instead of just one central activity.

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Shelf Life

As an aside, it does have a shelf life. After I made up a couple of million pills, I had to throw away large garbage bags full of old pills. They had begun to age. As they got older, they started to develop side effects, such as stomach gas, indigestion, headaches, and vision irregularities. So don’t use any Cialis that is over three years old. When I threw them away, there must have been five large green-black bags of pills that were thrown into the dumpster. Such a waste. Such a waste.

Anyways, I would have say that Cialis is the preferred conventional medication for ED, hands down.

Anyways…

The Design Team

Ah, but now for some bad news. What is really sad about it is what happened to all the researchers and developers who invented this product. You want to guess? Come on, what do you think happened to them?

Guess.

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Key team leaders in the ICOS Corporation developed the drug. They conceived it, they developed it and worked on it. However, the FDA has all kinds of testing and qualification hurtles that needed to be overcome. There was no way that the medicine would be approved. They were told this, and they knew that they had to link up with an “insider” or two to get the product approved. So the ICOS Corporation teamed up with Eli Lilly and Company to help get the drug approved through the FDA.

Of course, Eli Lilly is a big company with a lot of pull. They were able to “pull some strings” and get the drug approved.

As soon as they were able, Eli Lilly and Company bought the ICOS Corporation. They did so in 2007. It didn’t come cheap. They bought it for $2.3 billion. As a result, Eli Lilly now owned Cialis. As soon as they acquired the company, they immediately closed the ICOS operations. Thus they ended the joint venture and fired most of ICOS’s approximately 500 employees. Five hundred employees fired. Five. Hundred. Employees. Good Golly!

So…

Now you know [1] why the drug costs so much, and [2] why it sucks to work in corporate America.

Enter Levitra

This is an interesting little drug. It is a single dose drug like Viagra, but with a cost comparable to Cialis. It works a little bit differently than either of the two drugs already discussed. However, functionally it is like Viagra except it is made by a different company. You can consider it the Pepsi equivalent to Coke-cola.

I prefer it over Viagra simply because it interacts better with wine. I also like the (ahem) feeling I get when I use it. I feel (somewhat) better “packed” if you know what I mean.

What does it matter?

So now, men can take a pill and get an erection whenever they need it. Depending on where they live the access to this medication may be relatively easy (like in China) or restricted (like in America).

The thing is that life is not two dimensional.

It’s not ONLY about having a nice hard erection, it is about the mood, the feeling, and the emotions that you have when you are engaged in lovemaking. People, we are NOT animals. We have feelings and urges. Just getting hard and going through the motions is fine for a robot, but it is really weak compared to the real thing that you experienced when you were young.

For instance, consider the humble tomato. It was bred to look delicious, and ship safe. With taste being an afterthought. How we have thousands of tomatoes that look like plastic fruit and taste like cardboard. We have turned it into a two-dimensional shadow of what it was.

There are a host of things going on inside our brain when we are engaged in a sexual encounter. We express a litany of emotions, and feelings. We experience different sensations in our bodies. We connect and feel things that we share with our partners.

For both men and women, there are different aspects to a relationship that can be enhanced or (better yet) compensated for, instead just focusing on having an erection.

So…

Maybe we should start to pay attention to these other aspects of our life. Maybe we should consider them as playing an important role in our life. Maybe we should consider the entire aspect of who we are and what we are doing.

Enter PT-141 (Bremelanotide) Vyleesi

Instead of being a PDE5 inhibitor like Viagra and Cialis, consider a melanocyte stimulating hormone (MSH).  MSH induces lordosis in animal subjects. Or in other words, lordosis is a sign of physical preparation for copulation. It is a hormone that tells the body “get ready, we are going to have sex”.

It is a hormone that puts an animal in “heat”.

It is hardwired in our brains.  In animals such as dogs and cats, it tells the female to rise up their butts, and tells males to start thrusting. Now, as man has evolved this hormone has been repressed. We have replaced it with other cultural triggers. Or, in other words, what we visually see that has value has replaced this hormone. The natural lordosis behavior  has atrophied in humans.

Not so when you take this drug. This drug reactivates it.

This drug was being developed by Palatin Technologies. It showed great promise as it works equally well on both the male and the female sexes. (Though who knows about the other 55 genders that somehow mysteriously popped into existence under the Obama administration.)

It’s not only that men can get a nice sold and hard erection. It is more than that. People who take this also feel differently. People who take it feel young and horny like a sex-crazed 16 year old.

There’s only one problem. The FDA decided to ban it.

The FDA refused to permit Americans to access this drug.

Yes, it was banned in the United States, much to the surprise to all the doctors, scientists, and research participants.

They were shocked, as they should be. This was not just a “so so” drug. The test results were ASTOUNDING, and yet…yet… it was banned.

So, in defiance, the staff who developed this amazing medicines put it ALL out on the internet. That’s right. All of the chemical formulations, all of the test plans, and all of the documentation was uploaded to the Internet.

Just like Keannu Reeves did in the movie “Chain Reaction”.

There, for everyone to see, is the amazing test results and the absolutely stunning levels of corruption at the FDA.

They put it all out there. Everything, including the formulation and sequencing information.

Scientists talk among each other. It’s a small world. Sure, maybe the well-paid FDA bureaucrats ($440,000 / year just to say NO!)  are oblivious to this fact, and only chat with each other in their mansions and country-clubs, but the real workers, developers and key inventors care about their work and research.

In short order, it became obvious that the FDA was a corrupt organization, and that America had banned this medication because it would compete against Viagra. It also became obvious that this medication was very special. Very… very special.

If Viagra could be compared to a French Fry, PT-141 Vyleesi was a full thanksgiving meal with turkey, mashed potatoes, stuffing, salad, cranberry dressing, pumpkin pie and soft fresh buttered rolls. There is no comparison. None at all.

Not only that, but now the formula was available for everyone to replicate. As soon as it got out on the Internet, everyone was making it. People could buy it and try it and use it. Everyone, that is, except Americans.

So for the last two decades, this amazing drug has been used all over the world (outside of America) with amazing success, and absolutely ZERO fatalities. (So much for the so called, concerns about possible high blood pressure in a fringe section of the population.)

It has since become a legend. PT-141 Vyleesi is the stuff of dreams…

Pfaus showed me stunning testimonials from human test subjects. “On the five-point scale, I would rate the erection I had as a six,” said one of the 1,300 anonymous testers. 

"You get this humming feeling,” said another. “You’re ready to take your pants off and go.”

The drug worked equally well on women, who chronicled “an intense arousal” that lasted from six to 72 hours. “I was focused on sex,” said one of the women.

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Yes, but what is even more interesting is that this works on both men AND women. So while you might have a raging hard-on, your wife can now feel the same as you at the same time. She can feel like she was a sex-starved girl in the throes of “puppy love”.

Ah! What an amazing age that we live in!

“A dose of PT-141 results, in most cases, in a stirring in the loins in as little as 15 minutes. Women, according to one set of results, feel ‘genital warmth, tingling and throbbing’, not to mention ‘a strong desire to have sex’.”

-Julian Dibbell at ScienceBase

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User Stories

People can buy the PT-141 Vyleesi outside of the United States. And, they have been doing so for around two decades now.

The FDA has no jurisdiction off-shore, and people have taken advantage of this to try different kinds of medications for their own purposes.

You know, you don’t always have to listen to that busybody down the street to do things. So what if the FDA wants to FORCE you to pay outrageous prices for Viagra, and forbids you from using medications that you can get just about anywhere else on the planet.

You can hop on a plane and go to a nation that is freer, and get the medications yourself. I would suggest going to a nation that allows people more freedom than America allows.

“With PT-141 Vyleesi, you feel good, not only sexually aroused,” reported anonymous patient 007, a participant in a Phase 2 trial, “you feel younger and more energetic.” 

Said another patient: “It helped the libido. So you have the urge and the desire. . . . You get this humming feeling; you’re ready to take your pants off and go.” 

And another: “Twice me and my wife had sex twice in one night. I came in [to work] and I just raved about it: ‘Jesus, guys . . . 58 years old and you don’t do that.’ ” 

Tales of pharmaceutically induced sexual prowess among 58-year-olds are common enough in the age of the Little Blue Pill, but they don’t typically involve quite so urgent a repertoire of humming, throbbing, tingling, and double-dipping. 

Or as patient 128 put it: “My wife knows. She can tell the difference between Viagra and PT-141 Vyleesi .”

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The stories about this drug are amazing. Consider this from TheIronDen;

My buddy said research the stuff and see what the dosing was supposed to be because me made a HUGE mistake and took to much. He took double what we took and I will tell you DAMN!!! DOSING is .10-.20cc NO MORE below is the story.

As many of you know I am a bouncer on the weekends well I was told take this 45 minutes before going to bed, I had read where this could take a few hours to take effect so at midnight we went to the car and took the preloaded insulin pins I brought with me. 

Well I felt nothing and the wife didn't either by 3:30 when we got home. I was pissed at her and she didn't know it so watched TV awhile then I slept on the couch, she came in the next morning and woke me up, we went in the room and talked a min, then it was on. 

We have never had sex 3 times in 4 hours and she has never orgasmed 3 times in 1 day, we were so tired from sex that we couldn't hardly move and wanted more but our bodies wouldn't let us. bremelanotide  Vyleesi is AMAZING, I even wanted it last night, she was in the mood but couldn't as she has other medical problems and the pain in her hip was too much.

What it does:

Men - makes you horny as hell and increases blood flow to the cock making it more sensitive.

Women - floods the vagina with blood making it WAY more sensitive and very aroused.

Of this from a woman who took it with her husband…

3 hours after injection bremelanotide (PT-141)  Vyleesi hit like gangbusters.* 

We were sitting in the lounge area of a restaurant when my nether regions made themselves known. Increased sensitivity to any movement I made in my seat i.e. shifting or leg crossing. 

This was coupled with increased sexual thoughts. 

It is difficult not to think in sexual terms when some body parts are demanding your attention! My husband had a difficult time getting up from his chair to even approach the restaurant table. Next time we will time the injections better LOL

There are many, many…. MANY opinions by users, that actually run counter to the decisions made by the FDA.

I have to wonder if the agencies such as the FBI, FCC, FDA and IRS are actually being made to benefit Americans. I just seems like they all have their own agendas and treat American citizens like toilet tissue. It really seems that way. It really, really does.

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Heck, if the FDA was around when ice cream cones were first invented, I am sure that they would have banned them.

The same goes for such staples as Coke-cola, bananas (they will need to have a Blue Ribbon Panel study the “banana issue”), and chewing gum. Of course they would have banned chewing gum “for the children”.

Absolute power CORRUPTS absolutely.

When any agency causes more harm then benefit, it should have it’s doors shuttered and the workers discharged. Perhaps these “protected” governmental agencies should start to feel what industry has been like since the 1960’s for us “fly over” folk.

Women state that the sensation given from injecting bremelanotide (PT-141)  Vyleesi is like being in heat! 

One colleague in particular stated that she didn’t know what was going on…but she had wanted “it” all day long after dosing the night before.

-TheIronDen

• User details, dosages and experiences on AllThingsMale
• Dosing and history of PT-141
• User forum on PT-141
• Bluelight user forum for PT-141
• NY Mag writeup on this medication
• Comments on TheIronDen
• Why PT-141 is so wonderful for women
• PT-141 in an inhaler for quick and easy use
• Get PT-141 out of China

History and Timeline

Here’s a quick timeline of events that begins with Palatin Technologies’ submission to the FDA in the United States.

August 30, 2007

Right off the bat, the FDA declined Palatin Technologies’ application for approval of Bremelanotide to treat erectile dysfunction. The reason was there were “concerns” of increased blood pressure in a small percentage of the test subjects. Especially in light that Viagra was approved and it too had test subjects that had increased blood pressure.

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...the rejection of Bremelanotide by the FDA is especially puzzling, at least to a "lay person", when seeing posts online (including this one on the Yahoo finance message board for Palatin Technologies) claiming Palatin insiders have told them that only 2% of test subjects experienced a significant increase in blood pressure.

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 "It was up to 30 for 2 percent (I spoke to Steven W aka investor relations). The avg was 3. Not a medical person but those few people that hit the 30 mark killed brem."

Click here to read about the FDA decision about Bremelanotide

There are all kinds of conspiracies as to why this drug was declined because one or two of the thousands of test subjects had slightly raised blood pressure, when other approvals (with higher percentages of problems identified by test subjects) were approved.

I, such as myself, have speculated that huge companies (like Pfizer for instance) may have strongly influenced the FDAs decision regarding approval of this relatively small company’s competitive product. If you don’t know what I am talking about, watch the movie “Tucker, a man and his dream“.

September 10, 2007

Palatin Technologies and King Pharmaceuticals end their collaboration. Palatin regains full rights to the Bremelanotide program.

September 11, 2007

Competitive Technologies announced they presented Palatin Technologies with a Notice of Termination of the PT-14 technology license agreement. For those not aware, CTT “discovered” the original compound that led to PT-141 (Brem’s initial designation) via the University of Arizona, and licensed Palatin to develop it in 1998.

This issue was resolved on January 22, 2008 with Palatin paying $800,000 to CTT and maintaining the rights to Bremelanotide.

September 28, 2007

Palatin Technologies announced positive results from an at-home Phase 2 trial evaluating bremelanotide for the treatment of female sexual arousal disorder (FSAD).

Post menopausal women "showed statistically significant improvements, compared to baseline and placebo, in desire and arousal success rates, and overall satisfaction at one and two months. In these patients, the FSFI domains of arousal, desire and orgasm were statistically significantly improved compared to placebo at one month. The arousal and orgasm domains were statistically significantly improved compared to placebo at one and two months."

Premenopausal women also "showed statistically significant improvements, compared to baseline, in desire and arousal success rates, and overall satisfaction at one and two months."

May 14, 2008

Palatin Technologies reported it was abandoning Bremelanotide as a sexual dysfunction drug. Instead they intend to resubmit it to the FDA as a treatment for shock due to blood loss.

They are beginning studies for a new compound called PL-6983.  This compound works like Bremelanotide but with significantly lower problems related to blood pressure issues. Read Palatin Technologies’ 2008 Objectives plan here.

Then something happened... In 2016, Donald Trump was elected and immediately put businessmen instead of political hacks in charge of the FDA. Three years later...

July 1, 2019

The FDA approved the drug! I am absolutely shocked! As well as pleased. Very, very pleased. Now Americans can finally get what we in the rest of the world has enjoyed for almost two decades now.

It can now be bought in the United States under prescription. It goes by the name Vyleesi. I’m sure that it will be much more expensive for Americans to buy, but it will now be available, and that is a big step towards freedom.

• Vyleesi (bremelanotide) FDA Approval History

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Details

Here is a write up that has been circulating online over the last decade or so. As websites come and go, it behooves us to keep this information alive and available for all the poor sops in America who are FORBIDDEN from using this wonderful product;

What is Bremelanotide (PT-141)?

Bremelanotide (formerly PT-141) is the generic term for a new medication for use in treating sexual dysfunction in men (erectile dysfunction or impotence) as well as sexual dysfunction in women (sexual arousal disorder). It is a synthetic aphrodisiac. Unlike Viagra and other related medications, it does not act upon the vascular system, but directly increases sexual desire.

Originally, the peptide Melanotan II that bremelanotide was developed from was tested as a sunless tanning agent. In initial testing, Melanotan II did induce tanning but additionally caused sexual arousal and spontaneous erections as unexpected side effects in eight out of the ten original male volunteer test subjects. In clinical studies, bremelanotide has been shown to be effective in treating male sexual and erectile dysfunction as well as female sexual dysfunction. It is currently being tested by Palatin Technologies.

Bremelanotide is a cyclic hepta-peptide lactam analog of alpha-melanocyte-stimulating hormone (alpha-MSH) that activates the melanocortin receptors MC3-R and MC4-R in the central nervous system. It has the amino acid sequence Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH or cyclo-[Nle4, Asp5, D-Phe7, Lys10]alpha-MSH-(4-10). PT-141 is a metabolite of Melanotan II that lacks the C-terminal amide function. Its molecular formula is C50H68N14O10 with a molecular weight of 1025.2.

Are these nasal? Oral, Injectable?

Currently the nasal and oral routes have not been made efficient. PT-141 is a sterile injectable made for sub-q injection, like insulin.

What's the dosing schedule...how much do I take?

0.5mg-2mg is the range which people dose. Taking 2-4 hours before game time is ideal. The window of opportunity is very unique.

Say you had a dinner and movie arranged. Taking before dinner may be the best route, however during the climax of the movie may interfere with one of your own…read between the lines there

Is there any reconstituting involved?

Yes and bacteriostatic water is the recommended solvent here. 

To mix the vial with bact water, take one syringe (BD Ultrafine II 1cc or 1/3 cc are excellent and I recommend them) and grab your vial of bacteriostatic water. If using a 1 cc syringe (100 units), use the syringe to withdraw 1 full ml (1cc) and inject that into the vial of PT-141 through the rubber. 

Be sure to aim the needle towards the glass, so that it will trickle down and not harm the peptide. 

Swirl the vial to thoroughly mix and let the peptide dissolve. The key here is to be gentle. 

Say you had the vial of PT-141 stored in the freezer, move the vial of PT-141 to fridge for an overnight stay. Then you are ready the next day to reconstitute the same temperature refrigerated bact water with the PT-141 in the most efficient manner. (Just some tricks of the trade here.)

So now you have 100 units (1cc) of bacteriostatic water mixed with 10 mg of PT-141 in your vial ready to go. A 1mg dose would be 10 units or .1ml (.1cc). Make sense? Hope so.

How is it stored?

The lyophilized powder (freeze dried state) can be stored in the freezer or refrigerator. Once reconstituted (mixed with water) it will be good for a month in the refrigerator before it begins to degrade.

Does this help give erections or just put you in the mood?

With PT-141, you feel good, not only sexually aroused, as reported anonymous patient 007, a participant in a Phase 2 trial, you feel younger and more energetic.

The precise mechanisms by which PT-141 does its job remain unclear, but the rough idea is this: Where Viagra acts on the circulatory system, helping blood flow into the penis, PT-141 goes straight to the brain itself. And there it goes to work, switching on the same neural circuitry that lights up when a person actually, you know, wants to.

Basically this takes men back to middle school. You may find yourself in a similar situation as you were in 8th grade science class with the teacher bent over helping the student in front of you. It may be necessary to do a "tuck up" if at the office or especially at the public pool!

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Enter PL-6983

This is an “improved” version of PT-141 that doesn’t have any of the “concerns” that the FDA has raised. Of course, no matter how successful the medication is, the FDA will probably ban it’s use anyways. Anyways, this medication is under development currently and the formula is secret. Maybe one day, we can find out more about this medication. However, for now, we will have to wait.

PL-6983 is a synthetic peptide and selective MC4 receptor agonist which is under development by Palatin Technologies for the treatment of female sexual dysfunction and erectile dysfunction. It was developed as a successor to/replacement of bremelanotide (PT-141) due to concerns of the side effect of increased blood pressure seen with the latter in clinical trials. Relative to bremelanotide, PL-6983 produces significantly lower increases in blood pressure in animal models.The drug has reportedly been in pre-clinical development for all medical indications since 2008. Palatin has stated that "We are focusing development efforts on bremelanotide for [female sexual dysfunction], but are continuing evaluation of PL-6983." The chemical structure of PL-6983 has yet to be made public.

-Wikipedia

You can read about it in detail HERE.

Enter Oxytocin

You do not need to take various medications to enhance your bodies’ desire for sexual intercourse. There are hormones that do this. For example, Oxytocin is a hormone that also acts as a neurotransmitter in the brain and known as the “love hormone” or “cuddle hormone”.

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In humans, it is believed to be released during hugging, touching, and orgasm in both sexes. Oxytocin is also involved in social recognition and bonding, and may be involved in the formation of trust and generosity.

A researcher at the University of Zurich has stated that women are more susceptible to oxytocin than men, due to enhancing effects of estrogen, so women may show a stronger effect.

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If you are an American it would be pretty difficult to obtain. You would have to have your doctor prescribe it for you, and at that, it is heavily regulated and very expensive. Or, you could do what everyone else on the globe does. They buy it from China.

• Made in China website.
• Alibaba website.

Enter Flibanserin

Now, of course, women have different biology than males. Their urges, needs and desires can not often be switched on and off like a light-bulb. Consider Flibanserin. Here is a drug that showed some real promise in helping women reengage their sexual desire.

It was developed by a small company called Boehringer Ingelheim, and they submitted it to the FDA for approval. Of course, the FDA halted all approvals, and the development of this product ended.

Well, some “back door” meetings were conducted. Some money changed hands. Then, suddenly the rights to the drug were then transferred to Sprout Pharmaceuticals. What do you know? Suddenly all the roadblocks fell and the FDA approved of the drug in August 2015.

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Of course! Only certain companies are permitted to get products approved by the FDA. It’s a small closed club, don’t you know.  Hum. I wonder how much money exchanged hands at the FDA. I’ll bet that it was significant.

The product was developed as BIMT-17. Current brand name is Addyi.

Flibanserin has been dubbed the “Female Viagra” and “the little pink pill”; however compared to Viagra, flibanserin has a distinctly different mechanism.

The proposed mechanism of action of flibanserin involves regulation of several brain chemicals that may affect sexual desire, although the exact mechanism is not known. Flibanserin is a post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist, as noted in FDA briefing documents, and has action in the central nervous system. 

The manufacturer states that flibanserin corrects an imbalance of dopamine and norepinephrine (both responsible for sexual excitement), while decreasing levels of serotonin (responsible for sexual satiety / inhibition). 

Flibanserin is not a hormonal drug and does not affect blood flow like the class of drugs approved for men with erectile dysfunction.

-Drugs.com

Like all FDA approved medications, there are limitations.  The medication has to be taken daily and is costly, about US$800 per month with a prescription.

But no worries. You can buy the materials by the Kg in China, and only end up paying $0.0000002/dose. Of course, you would need to measure the dose out on a scale. So it is not as convenient.

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If you want to save money, and not have to worry about self dosing, I would suggest this far cheaper alternative.

1. Buy a round-trip ticket to China.
2. Get a five-star hotel room.
3. Go to a pharmacy, and pay $20 for a three month supply.
4. Return home.

You won’t need a prescription in China. The Chinese government trusts their citizens to know how to take care of their own bodies.

Contrary to what the American Media says, the Chinese government trusts their people.

What about Kisspeptin

Kisspeptin is a naturally occurring hormone, so it’s present in all men and all women. And it’s mainly found in the brain, especially in the center of the brain in the area called the hypothalamus.

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At the moment we know that it works to control other reproductive hormones like testosterone and estrogen using its actions in the hypothalamus. There are receptors for this hormone in the emotional areas of the brain.

In trials, 29 healthy young male volunteers were given an injection containing kisspeptin. They were then shown a variety of images while in an MRI scanner, including sexual and non-sexual romantic pictures of couples bonding. The same men were also administered a placebo during the two-stage controlled study.

Researchers analyzing the brain responses of the men found that after the injection of kisspeptin, when viewing sexual or romantic images of couples, there was increased activity in structures in the brain typically activated by sexual arousal and romance.

The researchers say the findings, published in the Journal of Clinical Investigation, show for the first time that the hormone that is vital in all of us to stimulate puberty can also alter the way that our brains behave.

Roll Call

So we have PDE5 inhibitors like Viagra and Cialis that enable the male to have erections. It doesn’t do anything in regards to feelings and emotions. All it does is enable men to perform biologically like they did when they were in their 20’s.

We have melanocyte stimulating hormones (MSH) that induces primeval lordosis in humans. This works on both men and women. The FDA forbids Americans to use this medicine, but it is being used around the world with great and stunning results. This is available in PT-141 and possibly (one day) in PL-6983.

We have normal human hormones such as Kisspeptin and Oxytocin that regulates feelings and emotions leading towards relationships and sexual activities.

Finally, we have “designer medicines” such as Flibanserin (Addyi). Which is a post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist for female use.

The Future

The future for Americans is rather bleak, I am afraid.

The House of Representatives voted on Friday to create a new schedule of banned drugs under the Controlled Substances Act, called “Schedule A,” and to give Attorney General Jeff Sessions broad new powers to criminalize the manufacturing, importation, and sale of substances that are currently unregulated, but not illegal. 

The bill is now headed to the Senate, where co-sponsors Dianne Feinstein (D–Calif.) and Chuck Grassley (R–Iowa) will likely have little problem whipping votes.

-Michael Krieger via Liberty Blitzkrieg blog

Did you know that the natural betel nut is banned in the United States? Do you even know what it is? It is a nut from the betel tree, and people in South East Asia chew it, much like Americans chew birch bark and leaves. It’s not at all popular in the United States, but in Asian expat communities, they do chew this nut.

Well, the FDA banned it. Do you know why?

Was it because it was dangerous? Was it because of “the children”? Was it because it might cause addiction or develop into a desire for other vices? Nope. It was banned because they COULD NOT find anything wrong with it. So to be safe, they banned it until they could find a benefit in chewing it. You know, “better safe than sorry”.

What kind of backwards logic is this? That is America for you. There is absolutely no freedom. Now, if you want to chew a betel nut you need to go to a freer country that allows you this little pleasure.

You need to go to a country that has more freedoms than America allows. You know, like friggin’ communist China!!!!

Summary

As an American, all we know is what we are told. We think that there is only one medication available for men with ED issues. When in reality, there are a host of solutions. It is just that Americans are barred from trying any of these other solutions simply because…

Simply because…

You, know. Because…

But not to worry. These medications are easy to get outside of the United States. They do not need doctors prescriptions or any proof of age or other barriers that one often finds in the United States. You just go to a pharmacy, write the name of the drug on a piece of paper, and they sell it to you directly at the cash register.

As you get older, you start to realize that “someday, I will...” is actually right NOW. There no longer is a “someday“. All you have is the NOW, and nothing else. You have friends who have died, and you truly know how short life actually is. You don’t have the will to wait for “someday…“.

You don’t have the time, or the patience to wait until some well-fed bureaucrat in the American government grants you the right to do things with your own body. You say “piss on this“, and go do it yourself anyways.

Every day that you live could be the last.

That moment that you could spend with your wife, holding and snuggling, while the storm rages outside might be your last. Those bureaucrats in Washington, D.C. don’t care about you at all. They are not sitting at the table with you now. They have no idea what color your socks are, and do not know which side of the bed that you sleep on.

How dare they TELL YOU what to put in YOUR body!

Freedom actually means something. It is not just a meaningless slogan that you hear on the fourth of July. It means something, gosh darn it!

The freedom to live your life on your terms is what freedom is. And that is why I am in communist China of all places. At least here, I can take whatever medication I please. No over-paid Washington bureaucrat can do anything about it.

Hey! I’m not seeing an opioid crisis over here…

Oh, and by the way! I like well-cooked bacon as well, with sunny-side up eggs! I like “runny” yellows on my eggs. You don’t like it? You can go to hell.

This is MY time and I am living it on MY terms. I strongly recommend that you, the reader, do so as well. You go live YOUR life as YOU see fit.

via GIPHY

Takeaways

• PT-141 is a superior ED medication.
• PT-141 is illegal in the United States, even though it’s qualification trials were acceptable. This is true even though this drug is available world-wide with no reported problems what so ever.
• To pass approval in the FDA, there is apparently a need for graft, kick-backs and large American-based company partnerships. Nothing is ever approved on merit alone.
• Americans do not need to suffer the extremely high costs of medications in the United States. They can get them outside of the USA at a fraction of the cost (airfare included).
• ED medication is often used recreationally by young men who don’t need it. However, there is a real and serious need for men over 40 years old.
• The roles of touching, cuddling, holding and passionate embraces are just as important than the sexual act alone.

FAQ

Q: What is PT-141?
A:Bremelanotide (tentative brand name Rekynda; former developmental code name PT-141) is a peptide melanocortin receptor agonist which is under development by Palatin Technologies as a treatment for female sexual dysfunction. It works equally effectively on both male and female humans.

Q: Is it available in the United States?
A: No. The FDA has banned it.

Q: Why is PT-141 banned in the United States?
A: The official reason is because a small subgroup of patients using the medication experienced higher than normal levels of blood pressure. The actual reason is because this is a small non-American organization, and they did not have any connections with large American pharmacy organizations to pay for the vice and graft that the FDA expected.

Q: Is PT-141 safe?
A: Yes. Since the product went globally public since 2007, there has not been one fatality or hospitalization when using this medication. NOT ONE.

Q: Other medicines in other nations cheaper than in the USA?
A: Oh, my yes.

"$8 per vial in competing developed-world nations and $38,892 in the U.S. That says it all."

-Charles Hugh Smith via OfTwoMinds blog

5JUL19 Update

The FDA approved Bremelanotide PT-141 for sale under the trade name Vyleesi. Amazing!

• Vyleesi (bremelanotide) FDA Approval History
• Bremelanotide FDA approval

And the “swamp creatures” in Washington DC are furious!

• FDA erred on women’s libido drug

A Final Quote

Dr. Robert Pearl, writing in Forbes last September illustrated the greed exhibited by the industry. He used the CEO of Nostrum Laboratories to make his point. Nostrum recently raised the U.S. price of their antibiotic nitrofurantoin from $474.75 to $2,392. It was developed back in 1953 and should have gone off patent during the Nixon era.

In an interview with the Financial Times, Nirmal Mulye Nostrum chief executive, said “I think it is a moral requirement to…sell the product for the highest price.”

Mr Mulye compared pricing decisions to that of selling “a painting for half a billion dollars”. He was “in this business to make money”. Of course, all businesses are in business to make money. But, none enjoy the monopolistic protections granted to the pharmaceutical industry here in the United States.

Note: a three day supply of nitrofurantoin tablets in Alberta sells for $15 Canadian.

The American system has been allowed to metastasize into an unaffordable monster. Our political leaders have allowed it. It is long past time for Americans to demand that they change it. This is not a matter of right versus left. It is a matter of right versus wrong. It is simply wrong for our government to allow sick Americans to be held hostage to the predatory prices imposed by these government protected monopolies.

Posts Regarding Life and Contentment

Here are some other similar posts on this venue. If you enjoyed this post, you might like these posts as well. These posts tend to discuss growing up in America. Often, I like to compare my life in America with the society within communist China. As there are some really stark differences between the two.

More Posts about Life

I have broken apart some other posts. They can best be classified about ones actions as they contribute to happiness and life. They are a little different, in subtle ways.

Stories that Inspired Me

Here are reprints in full text of stories that inspired me, but that are nearly impossible to find in China. I place them here as sort of a personal library that I can use for inspiration. The reader is welcome to come and enjoy a read or two as well.

Articles & Links

• You can start reading the articles by going HERE.
• You can visit the Index Page HERE to explore by article subject.
• You can also ask the author some questions. You can go HERE to find out how to go about this.
• You can find out more about the author HERE.
• If you have concerns or complaints, you can go HERE.
• If you want to make a donation, you can go HERE.

Notes

1. Composed 15JUN18.
2. Final composition 20JUN18.
3. SEO review 20JUN18.