It's official. the FDA has approved Addyi, or Flibanserin, the drug purported to treat female Hypoactive Sexual Desire Disorder (HSDD). You can read about it in the NY Times:
FDA Approves Addyi, a Libido Pill for Women
You may recall from my previous post, Addyi, that flibanserin started life as an antidepressant, failed at that job, then tried to reinvent itself as a libido drug, with completely unclear mechanism of action. Its original developer, Boeringer Ingelheim, gave up on it and sold it to Sprout Pharmaceuticals. Sprout measured desire in its original studies of flibanserin via a diary entry. In the first trial, there was no difference between placebo and drug in the outcome measure. Neither was there in the second trial, but then Sprout tried to switch the outcome measure to a subset of questions on a response questionnaire, the Female Sexual Function Index (FSFI), which the FDA considered questionable due, in part, to a 28 day recall period. The FSFI questions were used as the outcome measure in a third trial, with small improvement in desire.
The FDA did not want to approve the drug, mainly because it doesn't work, and it also has significant interactions with alcohol, involving syncopal events. (Notably, these were seen in men, back when it was being tested as an antidepressant.) Flibanserin is a standing medication, not PRN like Viagra, so interactions with alcohol are unavoidable, short of complete abstinence.
But Sprout turned the approval process into a political issue, starting a group called, Even the Score, which claimed the FDA was unwilling to help women with their sexual problems. Sprout got a number of women's organizations involved, and the FDA agreed to a review by an advisory panel.
And now, they've approved it. This is what the FDA has to say about it:
Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol. The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi. Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.
Addyi is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. Addyi is contraindicated in these patients. In addition, the FDA is requiring the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.
I'm very curious to see whether the FDA follows up on the "required" studies of risks of interactions with alcohol. I don't know what the consequences of non-compliance are, or how the FDA can enforce them.
This is really cynical of me, but I have significant reservations about a drug for women pursuing satisfying sexual interactions that makes them likely to pass out when they drink. Sounds like a new version of roofies.
On the upside, Sprout has agreed not to advertise Addyi on radio or television for 18 months, and to focus marketing on doctors, rather than consumers. Not that huge an upside. To that end, they plan to hire 200 sales reps, to cover 30,000 doctors, mainly OB/GYNs, but also some psychiatrists and primary care docs.
I tried to look up the Addyi REMS to see what's involved, but I couldn't find anything, maybe because Addyi won't be available for sale until October 17th. Personally, I'm not inclined to do the training.