Dear Friend and Fellow Athlete,

"On the five point scale, I’d score the erection I had as a six.”
- Patient 41

“The extended staying power is a plus because you can go again if you want to; there’s a possibility of another encounter...”
- Patient 207

“Because the drug is an initiator, I could approach sex more confidently, knowing beforehand that it would work. I felt more at ease and relaxed..."
- Patient 207

“…PT-141 was faster than Viagra® so I prefer it...”
- Patient 197

These are some of the comments that the human test subjects made about the PT-141 nasal spray that it currently entering Phase 3 trials at this time. As I wrote last week in Part One of the article New sex drug - ready for FDA approval - works on Men and Women - PT-141 could quite possibly represent the latest and most effective sexual arousal method known to man, or woman. Here's a link to Part 1 of our story on PT-141 and its effects on potency and sexual arousal in case you missed it.

This week, in Part Two of our story, we'll look closer at PT-141 and how it works. We’ll introduce you to the companies working to bring PT-141 to market. And we’ll look at the research and clinical trials that have been conducted so far.

PT-141 comes in a white plastic inhaler and is actually a potential future medication that can improve the sexual dysfunction not only in men, but in women as well. Unlike some of the current drugs that are designed to correct sexual dysfunction, PT-141 is the first one that could actually be considered a true aphrodisiac.

A good example of one of these companies is Palatin Technologies of Cranbury, N.J. who, in collaboration with King Pharmaceuticals Inc. of Bristol, Tenn., has taken the initiative in researching and developing the wonder drug PT-141 which is now entering Phase 3 clinical trials.

Palatin’s research of PT-141 actually didn’t begin with the medication itself but with the compound that it was derived from known as Melanotan II. Our longtime readers will remember that I introduced the world of bodybuilding to Melanotan back in June of 2003. Melanotan became know as the Barbie Doll pill because although the drug was developed to promote a suntan -- without the need to expose yourself to the sun, it also had many very desirable side effects. Hard as it is to believe, in addition to promoting a sunless tan, research subjects noticed that the drug produced powerful, spontaneous erections, raised the libido, acted as an anti-inflammatory, and suppressed the appetite. Imagine a drug that makes you look good, helps you get ripped, makes you horny, and gives you a boner – that’s what we’re talking about here. Here’s a link to my 2003 article all about Melanotan.

Tested as a sunless tanning agent, Melanotan II was a success, but the “side effects” of spontaneous erections and sexual arousal among its male volunteers intrigued the researchers at Palatin Technologies. The scientists ultimately broke down the Melanotan II compound into what would eventually become PT-141.

After breaking down Melanotan II into the offshoot compound PT-141, Palatin began conducting more thorough research on its possibilities as a remedy for erectile dysfunction. It was soon obvious that PT-141 worked wonders in the way of providing frequent erections for males and the way that it provided arousal through the brain was an interesting concept to the researchers. So interesting in fact, that it got them thinking about the possibility of using the drug to treat female sexual dysfunction.

Clearly, even more research needed to be conducted in order to uncover the implications of the drug for females and that left Palatin Technologies needing suitable guinea pigs, or should I say rats, for their experiments. So they approached Jim Pfaus, a behavioral-neurobiology researcher at Concordia University in Montreal. Pfaus was an obvious choice for this sort of research seeing as how he had previous experience working with female rats and their sexual responses.

Much of what Jim Pfaus had previously studied was the signs of foreplay that a female rat engages in with a male rat. If a female rat has found what she deems to be a suitable mate, she’ll make gestures such as wiggling her ears, wiggling her whiskers, nibbling at the male, or even the strange ritual of kicking him in the face, which by most creatures’ standards might be considered a bit of a turn off but not for rats. This is where PT-141 comes into play. Pfaus discovered that when the female rat was given the drug, her amount of foreplay increased and, in some cases, even led to the mounting of her preferred mate.

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While human responses can’t be completely mimicked through the use of rats, the effects that PT-141 had on female rats was still a strong indication of the drug’s proposed benefits nonetheless. In some views, rats may be an even better indicator of what PT-141 could do for humans. Rats don’t worry about the stigmas, awkwardness, and insecurities that often plague human test subjects and their interactions with sex researchers. Or as Jim Pfaus plainly stated, “The bad thing about animals is they don’t talk. The good thing is they don’t lie.”

Optimism is high about the potential benefits that PT-141 could provide for women. Jim Pfaus told the BBC, “There’s nothing in the arsenal to treat female sexual dysfunction. That’s one of the things that’s really promising about this drug.” Even more promising is that, so far, the drug has been proven to provide positive results for both males and females.

But before you rip out your debit card and run out the door in a rush to get to the nearest pharmacy so that you can purchase PT-141, hold on just a minute. PT-141 is only in phase III of clinical trials. While the outcome of a possible release of the drug looks favorable, it still must pass through the most difficult and time-consuming level of its trial. Even after passing phase III, PT-141 will still have to win over the approval of the Food and Drug Administration in phase IV of clinical trials.

Getting FDA approval is no cake walk and certainly not guaranteed. Failing to gain their support means that a drug may be put on restriction or withdrawn altogether. Some recent and notable drugs that have failed to pass phase IV of their clinical trials are the anti-inflammatory Rofecoxib (a.k.a. Vioxx or Ceoxx) because of its potential for causing heart attacks or strokes and the cholesterol minimizer Cervastatin (a.k.a. Lipobay and Baycol) due to its high number of serious side effects.

What does all of this mean? Well it means that the prospect of the highly anticipated PT-141 showing up on shelves in the near future isn’t simply a drop in the bucket. Long-term side effects of the drug are still largely unknown. Even assuming that it does gain FDA approval, PT-141 won’t be out on sale for at least 3 years. So to all the men suffering from erectile dysfunction, don’t go throwing your Viagra out the window just yet and for all ladies with sexual dysfunction, don’t cancel your next testosterone therapy appointment. It promises to be a few years before PT-141 is a valid consumer option for treating erectile and sexual dysfunction.

If however, you’ve been using research grade Melanotan or have been lucky enough to find research grade PT-141, we want to hear about it. Here’s a link to the EliteFitness.com Discussion Forums where we hope you will share your experiences with our fellow members. I’ll see you on the forums!

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