The drug industry’s decade-spanning search for a female equivalent to Viagra took a major step forward Thursday, as US government experts recommended approval for a pill to boost sexual desire in women.
The first-of-a-kind endorsement 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 develops a plan to manage its risks.
The recommendation is a major victory for a drug sometimes hailed as “female Viagra,” but which has been plagued for years by concerns of lacklustre effectiveness and safety issues. The FDA has rejected the drug twice since 2010. And a similar panel of FDA experts voted unanimously against the drug five years ago.
Thursday’s vote is non-binding but the FDA often follows the advice of its experts. An official decision is expected in August.
FDA’s experts acknowledged that flibanserin’s effect is not very strong, but said there is a need for FDA-approved drugs to address female sexual problems.