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Media Hypes PT-141 as Female Aphrodisiac of the Century

   
 

Part of Illustration by Yuko Shimizu in New York Magazine that ran with the story on PT-141. It fueled the current media frenzy. Click to story online.

 

Developer's stock soars as it enters next phase of clinical trials

Dec. 5, 2005 – There is nothing really new in the development of the possible sexual enhancement drug PT-141 – which has been hipped as being a powerful sexual enhancer for women – but there has been a media frenzy of stories, watched carefully by seniors citizens, on the possible aphrodisiac of the 21st Century. The only real news is that clinical trials are progressing but it is probably years from being available.

 

Related Stories

 
 

PT-141's Sexual Stimulation of Female Rats Grabs the Headlines

July 1, 2004 – Male sexual dysfunction has received most of the headlines in the last few years, much of it generated by the battle between drugs, like Viagra, that promise to solve the problem of poor sexual performance. But the headlines this week were grabbed by PT-141, a new treatment that reportedly increased sexual activity in female rats. Read More... 7/01/04*

FDA Fast Track for Female Testosterone Patch Questioned

Nov. 26, 2004 - The Food and Drug Administration (FDA) has granted a fast track review of testosterone patches for women with low sex drive, despite concerns about insufficient data and potentially misleading marketing by their manufacturer Proctor & Gamble, claim two articles in this week's BMJ. More... 11/26/04*

Women Beyond 50: A New Reality of Sexual Desire

Sexual interest may decrease in their 50s and 60s but see a resurgence of sexual appetite when they reach their 70s or even 80s.

Joyce sat on the edge of the examining table, dressed in a thin, faded gown. She felt vulnerable and a bit ridiculous. She was hoping that her doctor would be able to enlighten her about her declining interest in sex. More... 9/09/04*

Most Adults Won’t Give Up Sex for Staying Young, Seniors Won’t Give Up Coffee

April 20, 2004 – What are Americans willing to give up for a drink from the “Fountain of Youth?” Not sex, for those 18 to 64, and not coffee for those over 64. More... 4/20/04*

 More on Sex and Seniors - click here

 

Senior citizens, who are the most frequent to report problems with sexual ability, are certain to watch the development of PT-141 closely, as they did Viagra, which is now embroiled in thousands of civil suits due to medical problems. PT-141, however, increases desire and not just blood flow, as does Viagra and other current treatments, and is aimed at helping both women and men.

It's hard to say if it all the current reports started with a New York Magazine article released on November 11, or with the financial reports released November 8 by Palatin Technologies, the developer of the sexual-desire-enhancing nasal spray. Palatin reported a $6 million loss for the quarter and said a big factor was the development cost of PT-141.

Palatin also noted, "The initiation of two Phase 2B clinical trials during the quarter represents an important step in our development program for PT-141." The previously- announced trials include a definitive 'at-home' Phase 2B Efficacy study in approximately 600 erectile dysfunction (ED) patients, and an 'at-home' Phase 2B Efficacy study in approximately 250 ED patients with diabetes mellitus. (Click to the news release by Palatin)

Three days later New York Magazine released a news release on a news story. The promotion said, "The First Lust Drug: Is the world ready for libido in a nasal spray? PT-141 is a lot like Viagra -- except that it actually increases desire and not just blood flow and might help women as much as it does men. In other words, this is going to be a very popular drug."

The story by Julian Dibbell opened with, "Horn of rhinoceros. Penis of tiger. Root of sea holly. Husk of the emerald-green blister beetle known as the Spanish fly. So colorful and exotic is the list of substances that have been claimed to heighten sexual appetite that it’s hard not to feel a twinge of disappointment on first beholding the latest entry—a small white plastic nasal inhaler containing an odorless, colorless synthetic chemical called PT-141." (For the compete story online – click here.)

Then the media onslaught began.

"Is it the aphrodisiac of the 21st Century? 'It's a very simple product to use. Essentially, you take off the protective cap and place it at the base of your nostril and then they would just activate the device while breathing normally,' said Dr. Carl Spana of Palatin Technologies, Inc.," according to KRON 4 California Bay Area (click for report)

"Dubbed 'PT 141,' it works in women by sensitizing the vaginal tissue which in turn heightens sensation during stimulation," the station reported.

"It is a nasal spray that ignites lust. One sniff sparks a powerful sexual drive and it works for both sexes" said Stephanie Stahl, and Emmy-winning reporter at CBS 3 in Philadelphia. Her report was called, "Dose of Desire." (Click here to her report)

"Somewhere in the wilds of New Jersey a cage of happy rats is waking up this morning ready to get back to work. Their job? Improving your sex life." That's how Susan Cheever starts her column about PT-141 in the November 28 issue of Newsday.

 

Current News

 
   

"These beady-eyed pioneers in the name of love are the lab rats at Palatin Labs in Cranberry, N.J. They are in the final rounds of testing for a drug called PT-141, which will enable users to fall into an erotic trance at will with just the spritz of a nasal inhaler," writes Cheever.

"Called the love drug and the Barbie drug because it will presumably work for women as well as men, PT-141 is the new generation of sexual enhancement, which works directly on our brain chemistry. Viagra and Cialis act only on the vascular system," says Cheever. Read her well written column about PT-141 – click here.

"A new nasal spray aphrodisiac for women that works in minutes may soon hit the market," starts the report on Local 6 News in Florida.

"Doctors said women who used the drug PT-141 in test studies felt a tingling or throbbing followed by a strong desire to have sex immediately after spraying their noses," the station reported, along with graphics on how to use the spray..

The also quoted a Dr. Spana of Palatin as saying, "In the case of women, what we're really doing is sensitizing the vaginal tissue so when they get touched or stimulated, they would feel it a little bit more." (For the Channel 6 report – click here)

Not Everything Positive

It was not all positive, however. The Austin (TX) American-Statesman editorial board had to take a shot with, "Does it smell like turpentine? Look like India ink?"

In the December 3 issue they wrote, "Testing of the new drug PT-141 should produce a lengthy list of willing human guinea pigs. PT-141 is the 'love drug' that researchers say makes both men and women amorous within minutes of inhaling it in a nasal spray. It could be on the market as early as 2007.

"The drug is being lauded as the female version of Viagra, which stimulates arousal in men by increasing blood flow. But unlike Viagra, PT-141 stimulates receptors in the brain that are important in sexual arousal. While this version of Love Potion No. 9 is still being tested, don't be surprised if there are side effects. Viagra, we have learned, can cause blindness.

"There could be unintended consequences of the new love drug, too. It might mask deep problems in a relationship or exacerbate the already serious societal issue of mistaking sex for love. Not that those warnings will deter too many people, particularly those with sexual disfunction.

"The prospect of a love drug rings of Aldous Huxley's "Brave New World," the 1932 novel in which society solved its collective anxieties with the drug Soma ("All the advantages of Christianity and alcohol; none of their defects"). Can we really narcotize ourselves into states we desire and out of those we want to avoid?

"Looks like we're going to find out," concludes the Austin newspaper (click here to their page).

The stock of Palatin Technologies was one of the top gainers in the biotech group reported Burrill Biotech's stock report. Its shares closed up 58% in November even though financial results for their first quarter ending September 30, 2005 revealed the widening net loss due to the increased R&D costs related to PT-141.

When can you get it?

Don't rush out and ask your doctor for PT-141. It is a long way from the market. Definitive Phase 2B studies to evaluate PT-141 for treatment of ED in the at-home environment, and to select doses for Phase 3 studies, are scheduled to commence during the 2nd half of 2005, the company says. Phase 3 studies are projected to begin during the 2nd half of 2006. So, it's 2007 at the earliest before the data is accessed and presented to the FDA for approval.

Below is what Palatin says about their drug.

PT-141 is Palatin’s novel drug candidate for the treatment of male and female sexual dysfunction. First in a new class of therapies called melanocortin agonists, PT-141 has shown promise in effectively treating erectile dysfunction (ED) without the cardiovascular effects found in ED drugs currently available. PT-141 works through a mechanism of action involving the central nervous system rather than directly on the vascular system. As a result, it may offer significant safety and efficacy benefits over currently available products. To date, PT-141 has shown positive results in four Phase 2 efficacy studies enrolling more than 300 men. Palatin has also conducted a Phase 1 study in 32 premenopausal women without sexual dysfunction, in which the drug was shown to be safe and well tolerated. A Phase 2A pilot clinical study evaluating PT-141 in pre-menopausal women diagnosed with female sexual dysfunction (FSD) has shown encouraging results.

In August 2004, Palatin formed a collaboration with King Pharmaceuticals to jointly develop and commercialize PT-141 in North America for both male and female sexual dysfunction. Palatin and King will jointly seek a partner for PT-141 for territories outside of North America and will jointly share in development and marketing costs and all revenues generated from those territories.

PT-141 in Men

PT-141 has been evaluated in four Phase 2 efficacy studies enrolling more than 300 men. Phase 2 data was presented at the American Urological Association meeting in May 2003. Data from the Phase 2 at-home study was presented at the 8th Annual Leadership Conference on Sexual, Cardiovascular and Metabolic Syndrome Related Therapies in November 2003. The Company plans to begin Phase 3 trials in men in late 2006.

Key Clinical Findings from Phase 2 Studies:

   ● effective in a broad range of patients, including those with severe ED and those non-responsive to sildenafil

   ● efficacy in at-home studies is comparable to PDE-5 inhibitors

   ● up to 50% of ED patients were restored to a normal level of function

   ● co-administration with sildenafil shows superior efficacy

   ● side effects included:

       >  facial flushing

       >  nausea

       >  aftertaste

       >  post-nasal drip

PT-141 in Women

Palatin has conducted a Phase 1 study in 32 pre-menopausal women without sexual dysfunction, in which the drug was shown to be safe and well tolerated. A secondary endpoint in this study was the assessment of PT-141’s effect on vaginal blood flow. Results showed a significant difference in the increase in vaginal blood flow in subjects treated with PT-141 versus placebo.

A Phase 2A pilot clinical study evaluating PT-141 in 18 pre-menopausal women diagnosed with FSD has also been completed with favorable results.

Key Clinical Findings from Phase 2A Study:

   ● patients receiving PT-141 reported increases in their levels of sexual desire and genital arousal compared to placebo

   ● correlation found between sexual desire and genital arousal in patients receiving PT-141

   ● side effects were mild, including:

       >  nausea

       >  headache

       >  nasal congestion

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