A new "sexual desire" drug designed to boost women's libidos may not effectively do so, an advisory committee of the Federal Drug Administration said Wednesday.
Boehringer Ingelheim's Flibanserin "failed to demonstrate a statistically significant improvement ... of sexual desire," said an FDA review prepared for a panel hearing this week to discuss the drug's approval.
A team of FDA agency reviewers said the drug failed to increase sex drive among premenopausal women in two studies. The studies evaluated a combined total of 2,462 women worldwide over a period of 24 weeks.
The FDA review also showed increased side effects including depression, nausea, dizziness and appendicitis. It also said the side effects led 15 percent of women to stop taking the drug. According to a briefing report by Boehringer, the side effects were "mild to moderate in severity."
FDA experts will hold a meeting Friday to discuss the effectiveness and safety concerns of this "female Viagra." The approval of the drug will not be discussed until a later date.
Boehringer Ingelheim, one of the world's largest pharmaceutical companies, created the non-hormonal drug to help treat "hypoactive sexual desire disorder," which is a form of sexual dysfunction among women. According to a review by Boehringer, is it a "condition characterized by a persistent or recurrent lack (or absence) of sexual thoughts or desire for any form of sexual activity."
Since the approval of Viagra in 1998, more than two dozen therapies have been tried to study sexual dysfunction among females. It has expanded into an estimated $2 billion industry.
Scientists have been working on many methods of boosting the female sexual libido, but with little success so far.
Viagra and other drugs that boost blood flow to the genitals have not worked as well in women as men, while other drugs have sought to boost women's hormone levels. Filbanserin is the first drug that seeks to affect the brain chemicals related to sex drive.
While the drug did not increase women's overall libido, a small number reported having more sexually satisfying experiences and, according to the study recommendations posted at the FDA website Wednesday, the company has argued that this should suffice to declare the drug effective and let it be sold. But according to the advisory committee, that is not enough.
Kate O'Connor, associate director of communications at Boehringer Ingelheim, declined to comment until after Friday's meeting.
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