- In June, a panel of FDA reviewers voted 18 to 6 in favor of approving Addyi (flibanserin 100 mg). Those who opposed approval were vocal about their concerns.
- The main concern expressed by dissenters was that "the marginal clinical benefits outweigh the serious risks."
- One reviewer was concerned that the combination of Addyi (flibanserin 100 mg) and alcohol was tested mainly in men.
For Sprout Pharma, the third time was the charm with Addyi. After being rejected twice, first in 2010 and then again in 2013, this women's libido-enhancing drug was finally approved last month. However, behind the scenes there were several FDA reviewers who adamantly opposed approval of Addyi, mainly because of the serious risk associated with the combination of Addyi with alcohol. Addyi is a once-daily pill, which means that if a woman is taking Addyi and adhering to instructions, she will not drink at all. However, according to the Centers for Disease Control and Prevention (CDC), at leat 50% of women drink.
Regardless, the cacophony of Addyi advocates, including various women's groups and the coalition "Even the Score" (and the company itself) seems to have pushed the agency to approve Addyi, with numerous qualifications.
Addyi comes with a black box warning highlighting the risks of severe hypotension and syncope (fainting) in patients who drink alcohol. In fact, the label recommends bedtime dosing to help reduce the risk of adverse events associated with drug-related hypotension, syncope, and central nervous system (CNS) depression. There is also a risk of accidental injuries—an event that 2.7% of Addyi-treated women experienced in clinical trials.
In addition, the FDA attached a Risk Evaluation and Mitigation Strategy (REMS) to Addyi, which requires that healthcare providers and pharmacists watch an online slide presentation and take a test before they can prescribe or dispense it.
Within a week of approval, Valeant made a $1 billion offer for Sprout, which the company prompty accepted. It's too early to get precise feedback on product uptake, however, the likelihood of women experiencing negative side effects at least once while taking Addyi is highly likely.