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.
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*
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*
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*
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*
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 its hard not to feel a twinge of disappointment on first beholding
the latest entrya 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 Palatins 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-141s 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
