GAITHERSBURG, Maryland A pink sex pill offered little help to women and came with unacceptable risks, U.S. government advisers agreed on Friday, another setback in the search for a drug to boost female libido.
German drugmaker Boehringer Ingelheim failed to convince an expert panel that its pill increased sexual desire enough to win approval.
"The efficacy was not sufficiently robust to justify the risks," said Dr. Julia Johnson, the panel's chairwoman and head of obstetrics and gynecology at the University of Massachusetts Medical School.
Women reported depression, fainting, fatigue and other problems in company studies of the drug known chemically as flibanserin.
The once-a-day pill, taken at bedtime, is the latest attempt to find a female counterpart to Pfizer Inc's Viagra, the blockbuster blue pill for men.
Drugmakers have been searching for a medicine to improve women's sex lives since Viagra successfully debuted 12 years ago. The market for a "pink Viagra" could stretch into the billions of dollars.
But some doctors and advocates worry that pharmaceutical companies are playing on women's insecurities to convince them they need a pill to improve their sex lives.
"Low sexual desire is not a disease," said Leonore Tiefer, a clinical associate professor of psychiatry at New York University, reading to the advisers from a petition opposing approval of flibanserin.
The Food and Drug Administration will make the final decision on whether to approve the pill and usually follows the advice of its advisory panels.
LACK OF SEX DRIVE
Privately held Boehringer wants clearance to sell its pill by prescription for premenopausal women with a persistent, bothersome and unexplained lack of sex drive.
"Women deserve the option to choose a safe and effective pharmacological therapy for this distressing condition," said Dr. Anita Clayton, a Boehringer consultant and psychiatry professor at the University of Virginia.
The drug, originally developed as an antidepressant, is believed to act on brain chemicals thought to play a role in sexual response, the company said.
But the advisory committee of seven women and four men voted 11-0 that the drug's risks and benefits were unacceptable and 10-1 that effectiveness data was lacking.
FDA reviewers, speaking before the panel voted, said flibanserin failed to increase sexual desire as measured by women's daily diary entries in two company studies.
Boehringer said another analysis, based on a survey of women's responses, showed a jump in sex drive and lower distress levels with the drug.
Women also reported slightly more satisfying sexual experiences -- an average of 4.5 per month compared with 2.8 before taking the medicine. For placebo patients, the rate rose to 3.7 during the six-month studies.
Nearly 15 percent of women stopped taking flibanserin before the study ended due to possible side effects. Boehringer said most of the reported problems were mild.
Panel members, however, said they were worried women would take the drug for months or years with unknown risks.
"Long-term use needs to be better evaluated," said Dr. Kathleen Hoeger, a panelist and associate professor at the University of Rochester Medical Center.
The drug's proposed brand name is Girosa. It is not yet approved anywhere in the world.
"We are disappointed with the advisory committee's recommendations and will work with the FDA to address questions raised," Dr. Christopher Corsico, Boehringer's U.S. medical director, said in a statement.
While the committee voted against the drug, members encouraged Boehringer and others to continue pursuing sex medications for women.
"Indeed this is a significant need for women, and finding a medicine that will benefit women is critical," Johnson said.
Drugmakers have tested various ways to boost female libido, but women's sex lives have proved difficult to target with medication.
Male impotence pills including Viagra work by widening blood vessels to increase the blood flow needed for an erection. Pfizer dropped tests of Viagra in females in 2004 after studies failed to show it helped women.
That same year, an FDA advisory panel voted in 2004 against recommending approval for a testosterone patch made by Procter & Gamble Co, citing a lack of evidence for long-term safety. The patch was approved in Europe and has been sold to Warner Chilcott.
Another U.S. drugmaker, BioSante, is developing a testosterone skin gel to treat a decline in libido in menopausal women. The company estimates the U.S. market for treating female sexual dysfunction tops $2 billion annually.
(Editing by Lisa Von Ahn, Carol Bishopric and Tim Dobbyn)