FDA panel recommends approval for female equivalent of Viagra
05 Jun 2015
The drug industry's decade-long search for a female equivalent of Viagra advanced significantly yesterday, as government experts recommended approval for a pill to boost sexual desire in women.
The first-of-a-kind endorsement, however, came with safety reservations, however, due to drug side effects including fatigue, low blood pressure and fainting.
The panel of Food and Drug Administration advisers voted 18-6 in favour of Sprout Pharmaceutical's daily pill, flibanserin, on the condition that the company develope a plan for management of risks from it.
The recommendation marks a major victory for a drug sometimes hailed as "female Viagra," but which, had been plagued for years by concerns of lacklustre effectiveness as also safety issues. The drug had been rejected by the FDA twice since 2010 and a similar panel of FDA experts voted unanimously against the drug five years ago.
Though yesterday's vote was non-binding, the FDA often followed the advice of its experts. An official decision would be announced in August.
The regulator's experts said that flibanserin's effect was not very strong, but there was a need for FDA-approved drugs to address female sexual problems.
Meanwhile, according to commentators, the 18-to-6 vote came as a victory for Sprout Pharmaceuticals, which had pushed for flibanserin - proposed brand name Addyi – in the face of adverse decisions by the FDA earlier.
Following the last denial in 2013, the Raleigh, NC, company and its allies mounted an internet-based advocacy campaign called eventhescore.org that accused regulators of sexism and a double standard.
Following the vote, the company, in a subdued statement said, "we look forward to continuing our work with the FDA."
However, the decision came as blow to a coalition of women's health activists who believed the FDA was right the first two times: flibanserin's risks - including drowsiness, fainting, and low blood pressure - don't outweigh its marginal effectiveness.
According to Cynthia Pearson, head of the National Women's Health Network, the panel's daylong meeting showed the many unresolved questions about the seriousness, severity, duration, and frequency of flibanserin's side effects," which could be worsened by "alcohol, birth control pills, and a host of other drugs."
