An advisory panel of the US Food and Drug Administration, FDA, has voted 18 to 6 in favor of Sprout Pharmaceutical’s new female libido pill finanserin, providing the company develops a plan to manage risks.
The vote is not binding, but the US health watchdog is generally said to follow its advisers’ recommendations. FDA had rejected the pill twice since 2010, and another advisory panel voted against it the same year.
Finanserin, which acts on serotonin and other brain chemicals, was originally studied as an anti-depressant but was repurposed. Since the launch of Pfizer’s male libido pill Viagra in 1998, calls for a drug to treat female sexual dysfunction had become louder.
The FDA panelists expressed concern about certain safety issues, including low blood pressure and fainting, especially when finanserin is used together with alcohol and commonly used medications. Remarkably, Sprout studied the alcohol interaction with a group of 25 mostly male patients.
If it wins approval, the drug would be recommended for premenopausal women with hypoactive sexual desire disorder. Before prescribing, doctors would be required to eliminate a number of alternative causes, including depression, relationship problems and mood disorders.
One critic of the panel’s decision, Dr Adriane Fugh-Berman of Georgetown University in the US capital of Washington DC, said approving the drug “would set the worst kind of precedent,” namely that “companies spending enough money can force the FDA to approve useless and dangerous drugs.”