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Intrinsa stalled by concerns about safety

An FDA advisory panel called for more and longer-term data regarding this treatment for female sexual health problems.

By Kathleen Phalen Tomaselli, amednews correspondent. Jan. 17, 2005.

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Touted as female Viagra, Procter & Gamble's testosterone patch for women, Intrinsa, was slated as the next blockbuster lifestyle drug. But the U.S. Food and Drug Administration Advisory Committee for Reproductive Health Drugs put the brakes on its fast-track approval in early December 2004.

And since Dec. 21, 2004, Intrinsa's manufacturer has been confirming its intent to withdraw the current FDA application and resubmit a new application to address concerns raised by the advisory panel.

"The 17-0 vote really focused on safety," said Irwin Goldstein, MD, professor of urology and gynecology at Boston University School of Medicine and director of its Institute for Sexual Medicine. "[The manufacturer] needs to document more than six months of data."

Intrinsa would have been the first FDA-approved drug for women with sexual health problems. And despite the call for more safety data, Dr. Goldstein said, this is a new arena. Historically, women's sexual problems have been viewed as being in the brain rather than the body, so the fact that there's a drug in the pipeline designed to address an altered biochemistry is promising.

"The efficacy was favorably viewed by the committee," he said. "When a new class of drugs comes out, it's exciting, and to one day get approval by a government regulating agency for the treatment of women's sexual health ... it has never happened before. Hopefully, this is the beginning."

Worn on the abdomen, Intrinsa releases a small amount of natural testosterone in an attempt to compensate for a drop experienced by some women as they age. The 24-week randomized, double-blind, multicenter trial was limited to surgically menopausal women with hypoactive sexual desire disorder. Participants recorded an increase in satisfying sexual activity versus placebo. Still, the committee focused on the study's limits rather than the drug's efficacy.