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,

Robbinsville

08691. Joseph Mo, chairman, CEO, and president. 609-208-9688; fax,

609-208-1868. Home page: http://www.nexmed.com.


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