The pharmaceutical industry is waiting eagerly for the FDA to take a vote on whether to approve the controversial new drug flibanserin, which is designed to treat Hypoactive Sexual Desire Disorder (HSDD) in women.
The FDA has already released a report, prepared as background information to the vote taking place today. It expresses concerns about the safety of the drug, directing the committee to consider whether women would be alerted by the labelling to the extensive possible drug interactions. It also expressed concerns as to whether members of the general public taking other medications or with histories of psychiatric disorders would respond well, as the report stated that the population taking part in the trials were generally healthy and taking few, if any, concomitant medications.
Aside from issues of safety and tolerability, the prospect of the drug being approved has stirred up a huge amount of debate over whether this is just a case of the pharmaceutical industry trying to profit from women’s sexuality.
While Boeringer (the company that developed Flibanserin) has launched an aggressive campaign to educate the public about HSDD (including a documentary for the Discovery channel and a tour by an ex-Playboy model who describes herself as suffering from HSDD) there is still a huge amount of concern that the underlying psychological causes of low libido might be ignored.
Some doctors believe that HSDD can be treated medicinally, others believe in psychotherapy and counselling. Perhaps the only thing that will decide the best way forward is when there is a medication available, offering women options to treat the condition.
That choice could still involve Flibanserin. As the New York Times pointed out, staff reports do not necessarily indicate which way an FDA panel will vote, and even the vote does not predetermine the final decision. Watch this space...