FDA’s Advisory Panel Recommends First Drug for Female Sexual Dysfunction
The Food and Drug Administration’s voting in favor of a drug aimed to help combat female sexual dysfunction marks a turning point in women’s sexual health.
The 18 to 6 vote on Thursday has led the dream of a pill to treat lack of sexual desire in women much closer to reality. Sprout Pharmaceuticals, owner of flibanserin, is quite positive that the agency will approve in mid-August.
The recommendation has finally put an end to a long debate over the issue to which level female sexual dysfunction is genuine problem. Debate also involved questions, including whether drugs should be taken to treat the problem and why there is no such drug for women when many drugs are available in the case of men.
It shall, however, be noted that the voting has come with a caution. In warning, a program is needed to highlight the side effects and interactions with other medicines. The panel has raised concerns over dizziness taken place nearly five times among women taking drug in comparison with a placebo.
Sleepiness and Faint incidents were also other issues. The panel also expressed concerns over interactions with drinking alcohol. There was a rise in number of satisfying sexual events, but they were measured on monthly basis and not on daily basis.
For two times, the drug was rejected by the FDA. Even a campaign, ‘Even the Score’, was started, which was joined by Sprout and consumer advocacy groups. Main aim of the campaign was to press the FDA to approve the drug.