Testing sought on drug for women
Marie Sanchez, Globe Correspondent
10/25/98
The Boston Globe
City Edition
Page A14
BURLINGTON -- Researchers for the Boston University School of
Medicine are seeking FDA approval to conduct human trials on the most
promising of several recently developed therapies aimed at improving
female sexual response.
Prompted by women asking for Viagra and by pharmaceutical companies
searching for profitable new products, scientists have developed a gel
and spray for the vaginal area that increases blood flow locally without
the side effects that have been linked to Viagra, such as complications for
people on heart medications.
"Viagra opened the door," said lead researcher Irwin Goldstein,
professor of urology at BU who specializes in men's and women's sexual
disorders. "We're being forced to address women's problems."
Tiny capsules, or liposomes, that carry a powerful drug to dilate blood
vessels have been tested on men.
When Goldstein tested the therapy on female rabbits, they absorbed the
drug via the vaginal lining, increasing blood flow by up to 60 percent, he
will announce in Burlington today at the inaugural symposium on New
Perspectives in the Management of Female Sexual Dysfunction.
Circulatory and nerve problems are major physical causes of female
sexual disorders.
Data on how many women are affected by such disorders are scarce, but
the 1994 National Health and Social Life Survey showed that out of
1,500 women ages 18 through 60, sexual problems were reported by
half, spanning socioeconomic and age groups.
Up to 40 million American women will be afflicted by 2000, according to
statistics by the Women's Center for Reproductive Health.
Female sexual disorders have strong emotional and social components.
Women most commonly complain of a lack of sexual desire or orgasm,
and difficulties with lubrication or penetration.
These problems have a strong impact on women's perceived quality of
life, said Sandra Leiblum, professor of clinical psychiatry at the University
of Medicine and Dentistry in New Jersey.
Today, professionals are helping women with counseling, limited hormone
treatments, and artificial lubricants. But as more women ask for help, they
spur further research, which in turn drives new therapies, Goldstein said.
Darryl See, clinical director for Harvard Scientific , a Florida- based
biopharmaceutical company that financed the BU research, said the
market for these new therapies could reach $2 billion to $10 billion a
year, if figures for men's products are any indication. (About 30 million
men suffer from erectile disorders.)
For years, prostaglandin E1 has been used to open heart vessels. Now
the patented liposome system offers a new use, and human trials could
start late November, See said.
Competing firms are trying to develop treatments that deliver the drugs
through the skin, as with vaginal suppositories.
Still others are using phentolamine in pill form to increase blood flow.
And pills using a Viagra-like agent are now in first-phase human trials.
See estimates that it will probably take 18 to 24 months for the first
therapies to hit the drugstores.
Harvard Scientific 's gels and sprays would be priced at $12 for a small
bottle, See said, and each would hold four applications, lasting about an
hour per dose. They could be safely reapplied immediately.
Emotional and psychological considerations notwithstanding, See said
that if the new therapies live up to their potential, they could usher in a
"new moment in the sexual revolution" by giving women greater
confidence in social and sexual situations.
"There was the {birth control} pill in the '60s," he said. "The 'new pill' in
sexual arousal could improve the quality of that encounter."
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