Home Chemistry FDA votes to approve Addyi, the Viagra for ladies

FDA votes to approve Addyi, the Viagra for ladies

Depending on who you talk to, Thursday was a watershed moment for the advancement of treatment options for women’s sexual health. The FDA’s advisory panel voted 18-6 to approve Sprout Pharmaceuticals’ filbanserin, which would be marketed under the name Addyi. The FDA will take action as soon as September, though they most always follow the recommendations of their advisory panel. If approved, it would be the first-ever drug created and prescribed for the sole purpose of enhancing female libido.

Though viewed as a big win for women by many, not everyone (nor all women) think the drug is worthy of approval, due to its risk-benefit ratio.

“The benefits are modest, maybe less than modest, but I’m afraid that puts [flibanserin] in good company with other approved drugs,” said adviser Walid Gellad, codirector of the University of Pittsburgh’s center for pharmaceutical policy. “I also have serious safety concerns.”

In early clinical trials, filbanserin increased the number of monthly “satisfying sexual encounters” by one over a placebo – statistically significant, but unremarkable in real-life terms. Proponents of the drug argued that measuring the number of sexual encounters didn’t capture the intent of the drug, and instead recommended monthly questionnaires designed to measure level of desire, which the drug is intended to treat. The researchers claimed that by these measures, filbanserin significantly outperformed the placebo.

In the other corner are those worried about the side effects, which opponents say outweigh the drug’s questionable benefits. They include dizziness, fainting and low blood pressure, and are worsened when filbanserin is taken in conjunction with many commonly prescribed drugs, or with alcohol. Because alcohol itself lowers blood pressure, its effects can be compounded when consumed with the drug. The manufacturer had trouble finding enough women moderate drinkers to conduct proper trials, but in one instance, three out of 25 women experienced fainting spells due to low blood pressure, which concerned the FDA.

Another issue is filbanserin’s side effects when taken with certain depression and anxiety medications, which many women cite as the source of their inhibited libido in the first place.

This is the drug’s third attempt at approval, after being rejected in 2010 and 2013 by the advisory panel. A group called Even the Score, which has lobbied for the drug, point to the fact that men have some two dozen approved drugs for erectile dysfunction, with side effects that include blindness and penile rupture. To them, rejection of the filbanserin meant giving men more autonomy to weigh risks versus rewards than women. Libido and a functioning penis, however, are not the same things.

Sprout Pharmaceuticals agreed to include strong label warnings for the drug, and to refrain from direct-to-consumer advertising until doctors have sufficient time to learn about and understand the drug. Only time will tell.