Improves desire in women whose ovaries were removed

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Procter & Gamble on Wednesday moved a step closer to becoming the first company with a drug on the market to treat sexual dysfunction in women after releasing data from a pivotal late-stage clinical trial that backs up its previous findings.

The testosterone skin patch, to be called Intrinsa, significantly improved sexual desire and satisfaction in women whose ovaries had previously been removed, according to data to be presented on Friday at the Endocrine Society of America annual meeting in New Orleans.

Armed with data from two large phase III clinical trials that appear to demonstrate safety and efficacy of Intrinsa, P&G believes it now has the information needed to seek approval from U.S. regulators.

Available next year
Although the company declined to discuss when it would file its new drug application with the Food and Drug Administration, P&G spokeswoman Mary Johnson said if approved they hope to have Intrinsa available by prescription sometime next year.

The drug would be prescribed to increase sexual desire in menopausal women who have experienced loss of desire and are distressed by that loss.

“This is huge,” said Sheryl Kingsberg, an associate professor of reproductive biology at Case Western Reserve University and one of the lead investigators of the trial.

“It’s important to get it out there because we don’t have any approved medical treatment on the market for female sexual dysfunction that clinicians can look at as safe and effective,” Kingsberg said.

In P&G’s latest 24-week trial of 533 women, patients taking Intrinsa reported a 51 percent increase in frequency of “satisfying sexual activity” and a 49 percent increase in sexual desire, compared with their previous experience.

The response rate was lower than in a previous trial, but researchers said the findings were statistically significant.

In a similar study of 562 women released in May, women receiving the patch had a 74 percent increase in frequency of satisfying sexual activity and a 56 percent increase in sexual desire.

Female Viagra elusive
P&G, best known for consumer products such as Tide laundry detergent and Crest toothpaste, said it is currently conducting two more late-stage clinical studies of the testosterone patch in menopausal women who have not had surgery to remove their ovaries, Johnson said.

The search for a so-called female Viagra has so far proved elusive. Even Viagra-maker Pfizer abandoned their program of testing the drug for women, whose sexual dysfunctions are more varied and complicated than men.

“In any area of research, women’s research always lags behind men,” Kingsberg said.

Analysts have said drugs for female sexual dysfunction that prove effective in treating problems with desire, arousal or ability to achieve orgasm could garner sales in excess of $1 billion a year.

Vivus is developing a drug to treat the arousal component of female sexual disorder that it hopes to submit to the FDA in 2006. It also acquired rights to a female sexual desire treatment that may compete with Intrinsa.

“The launches of these drugs, starting with Intrinsa, will prompt a wave of marketing that will likely raise awareness of Female Sexual Dysfunction,” David Lapidus, analyst at Decision Resources, said in a report.

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