Corrections or additions?
This article by Melinda Sherwood was published in U.S. 1 Newspaper
on September 15, 1999. All rights reserved.
Putting the Spark Back in the Sex Life: Viagra for Women?
The development of Pfizer’s Viagra to treat erectile
dysfunction is popular among men, some women, and — overwhelmingly
— the press. But in reality, sexual dysfunction among women is
even more common than it is among men and also more complicated. It
affects an estimated 47 million women, mostly post-menopausal, in
a variety of ways, from depressed libido to inability to reach orgasm.
But when men reach for the Viagra, what do women have to turn to?
Danielle Steele?
In the race to develop the female equivalent to Pfizer’s Viagra,
researchers
at NexMed, a drug development company at 350 Corporate Boulevard in
Robbinsville, have high expectations. It’s not a pill, but a cream
called “Femprox” that researchers have developed. The cream
just completed Phase I clinical trials at Robert Wood Johnson Medical
School, where eight women subjects were treated with the experimental
substance and then placed in front of “sexually explicit”
videos. A “statistically significant” number attested to a
heightened state of arousal. Doctors conducted a physical exam of
the subjects to confirm. So far, so good.
But eight people is a minuscule sample: Clearly it’s too early to
get excited. Femprox still has several more steps in the clinical
trial process before and if it receives approval from the FDA. It
could be a while, says Vivian Liu, CIO for NexMed. “If everything
goes well in terms of financing, licensing, FDA approval, we hope
to have it on the market maybe by 2001,” says Liu.
Femprox is essentially a byproduct of research conducted on NexMed’s
Alprox-TD product, a cream used to treat erectile dysfunction. In
clinical tests that began in 1997, researchers discovered that
partners
of test subjects received some of the benefits. The active ingredient
in both the male and female creams is alprostadil, the chemical used
in existing treatments like Caverject, an injection by
Pharmacia-Upjohn,
and Muse, an intraurethal system made by Vivus. What NexMed brings
to the equation is its patented transdermal “enhancer
technology”
called NexAct, which allows drug compounds applied topically to be
absorbed into the body quickly. Alprostadil itself flicks the erotic
switch. The drug, a vascular dilator, increases blood flow to the
regions on which it is applied.
Theoretically, it should work for women for the very same reason it
works for men, but what’s good for the gander, is not necessarily
good for the goose. In matters of sexuality, men and women could not
be less alike, despite their common bond. Andre T. Guay, an
endriconologist
and director at the Center for Sexual Function in Massachusetts, says
that sexual dysfunction in women goes beyond “impotence.”
“Most of the women I see in my clinic have libido problems,”
says Guay. The benefits of a vascular dilator would pretty much be
lost in such a situation. The same thing might be true for women who
have problems reaching orgasm.
But the center is only just beginning to study sexual dysfunction
for women. In that pursuit, says Guay, researchers have to break
through
some of the same perceptual barriers that held research on impotence
back. “It’s a mirror image of what we did with men 20 years ago
when 95 percent of doctors thought it to be a psychological
problem,”
says Guay.
That’s less the viewpoint of scientists today, however, most of whom
find plenty of culprits in female physiology, not psychology. Guay,
who received a BS in biology from Boston College, Class of 1964, and
a medical degree from New Jersey College of Medicine, believes that
testosterone levels play an important role in determining the female
sex drive, and hopes to expand knowledge in the medical community
as a whole by working with Pfizer on tests of a female product similar
to Viagra.
Testing his hunch won’t be as easy it sounds, though. In the world
of medical research, women and men are not yet equally understood.
“We need whole new tools,” he says. For the purposes of his
research, the assays, a tool used to measure testosterone levels in
men, aren’t sensitive enough to pick up levels of the hormone in
women.
“We’re missing an awful lot of data on anatomy, chemistry, and
physiology of the female sexual response,” he goes on. “We
started studying men 15 years, ago and we just started five years
ago with women. Right now we’re just trying to adapt male treatments
to women. It’s not smart, you’re asking for potential problems. You’re
guessing and those of who work in this area don’t like to guess.”
Femprox, NexMed’s topical for women, is very much a retrofit female
treatment, but then again, that’s the typical course of drug
development
in this area, says Liu. “A lot of developers of male products
are looking at the female side,” she says. “NexMed is probably
one of the more advanced because we have completed Phase 1.”
Healthy,
young “pre-menopausal” women were the subject of those tests,
in spite of the fact that post-menopausal women are the ones who
largely
suffer from sexual dysfunction. “Female sexual dysfunction is
complicated, but we know that a lot of women have it because of
physical
symptoms, and that’s what we’re treating,” says Liu
Among the pharmaceutical companies racing to get a love
elixir for women on the market: Pfizer, Palatin Technologies,
MacroTech
Corporation. Palatin Technologies, based at 214 Carnegie Center, is
working on a drug called Erectide, a peptide hormone analog that could
be used as both a therapy and diagnostic agent in the treatment of
male impotence. The same technology could theoretically be used to
treat female sexual dysfunction, says Christine Blood, director of
biological research at Palatin. “I think that the potential is
there but the data on that is pretty scant,” she says. “There
really is not a whole lot known about the mechanisms of sexual
dysfunction
in men and women, but there’s a lot more data on the male sexual
dysfunction
than the female.”
MacroTech Corporation, based in Lexington, is testing TopiGlan,
another
alprostadil-based drug that uses technology similar to NexMed’s to
promote topical absorption. Then of course, there is Pfizer, which
just completed Phase II tests of Viagra on women.
Taking a pill may sound preferable to smearing on a messy salve, but
Liu believes NexMed’s topical will appeal to a considerable market.
“It’s not necessarily a head-on competition issue,” she says.
“We know of patients can not take Viagra — they’re on nitrate
medication and they would die.” The topical, she adds, may fit
into a lifestyle choice. “Some people like the anonymity of the
pill, but some people don’t like the idea of the pill traveling
through
the body,” she says. “If you have a pain in your knuckle,
why take something that has to go throughout your entire circulatory
system?”
When U.S. 1 reported on NexMed in 1998, Phase 1 clinical trials on
Alprox-TD had just been completed. The Chinese-born and
Taiwan-educated
CEO of NexMed, Joseph Mo, who holds a PhD from Purdue University,
had hoped to release Alprox-TD to the 20 million men suffering from
impotence as well as recreational users by 2000. NexMed’s one and
only other product — Viratrol, is a hand-held device for treating
oral and genital herpes with low level medical currents.
None of these products have made it to consumers yet. Clinical trials
for the female and male creams won’t be complete for at least another
year, and Viratrol, which has been approved in Canada, has not yet
been marketed.
Liu, who holds a BA in international trade from Berkeley, Class of
1983, says that NexMed can’t, and doesn’t expect to, get its products
on the market single-handedly. “We don’t have the manpower or
staff to look after the marketing and educate the consumer,” she
says. “We need the marketing muscle, and we’re in discussion with
large licensing partners, mainly multinational pharmaceutical
companies.
If you look at the development of all small pharmaceuticals, they
always get into bed with the SmithKlines and J&Js. Why would you
go out and reinvent the wheel?” NexMed does plan to keep
proprietary
rights to the technology, however.
NexMed’s herpes treatment, Viratrol, could be one of the most
ambitious
innovations on the market. It’s a treatment for herpes that uses a
hand-held, non-invasive device to impart a low-level electric current
to the infected site. Treating either oral herpes or genital herpes,
the microchip-controlled current reportedly blocks lesions from
forming
and shortens the healing time of existing lesions. Viratrol was
approved
in Canada, but again, NexMed is waiting for the right company to scoop
up the technology.
“It’s a development stage company. It will be in the red for
awhile,”
says Liu, “until it completes a licensing partnership.” Liu
estimates that the company’s burn rate is about $250,000 per month.
Meanwhile, Femprox is scheduled to go onto Phase II of clinical trials
— testing for safety and efficacy — as per FDA protocol. It
could be one of the first female sexual dysfunction treatments to
make it market. But — mindful of a recent article in Modern
Maturity
in which some women complained about Viagra creating randy husbands
— gentlemen perhaps should be careful what they wish for.
NexMed Inc. (NEXM), 350 Corporate Boulevard,Robbinsville08691. Joseph Mo, chairman, CEO, and president. 609-208-9688; fax,609-208-1868. Home page: https://www.nexmed.com.Previous StoryNext StoryCorrections or additions?This page is published by PrincetonInfo.com— the web site for U.S. 1 Newspaper in Princeton, New Jersey.
