Unlike its counterpart medications for male erectile dysfunction like Viagra or Cialis, Addyi will not be taken on an “as needed” basis. Citing differences in sexual function between men and women, clinical sex therapist Judy Kuriansky said, “Women’s sexuality is very complicated. It’s not a matter of just taking that pill, by the way, and then all of a sudden the lights go on.” Kuriansky added, “You have to feel good about your body. You have to feel good about yourself. You have to feel the guy really loves you. It’s complex.
On Tuesday, the U.S. Food and Drug Administration approved the libido-enhancing drug for women Flibanserin, which will be sold commercially under the name Addyi. The approval comes after two prior failed FDA applications, the first submitted by Boehringer Ingleheim in 2010 which an FDA recommendation panel rejected due to the drug’s lack of effectiveness and side effects that were deemed to be too severe. A revised application was submitted in 2013 by Sprout pharmaceuticals, which bought the rights to Flibanserin in 2012 after Boehringer discontinued research on the medication, again rejected by the FDA panel, this time without a review. Sprout appealed in 2014, however, with the FDA issuing guidance on how to create a successful proposal. Sprout resubmitted its application, relying heavily on data from a 2013 study in the Journal of Sexual Medicine, citing that women who take the drug have 2.5 “satisfying sexual experiences” every four weeks as opposed to 1.5 for women who did not take the drug. On June 4th, the FDA advisory committee voted 18-6 to recommend Flibanserin for approval, a suggestion that, while not binding, the FDA usually heeds.
Unlike its counterpart medications for male erectile dysfunction like Viagra or Cialis, Addyi will not be taken on an “as needed” basis. Citing differences in sexual function between men and women, clinical sex therapist Judy Kuriansky said, “Women’s sexuality is very complicated. It’s not a matter of just taking that pill, by the way, and then all of a sudden the lights go on.” Kuriansky added, “You have to feel good about your body. You have to feel good about yourself. You have to feel the guy really loves you. It’s complex. It’s not the same as a man taking a pill.” Indeed, Addyi is designed to affect the central nervous system and taken once every night, with the FDA putting the drug in the same class as antidepressants. Although Flibanserin’s efficacy has been marginal considering the cost over large population samples, the FDA based its approval on the small proportion of women who gained an exceptional increase in desire, as well as due to the lack of alternative sexual therapies for women.
Despite its approval, Flibanserin comes with a host of side effect warnings. The FDA approved the drug with a risk evaluation and mitigation study (REMS), which will require monitoring of the drug’s most severe side effects, including dizziness and loss of consciousness. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research also noted, “Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies. Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.” Other components of the drug’s “box warning,” include not taking Addyi if a woman has liver problems, or is taking medications called CYP3A4 inhibitors. Forbes pharmaceutical analyst John LaMattina believes that doctors may be hesitant to prescribe the drug, given the training required and the side-effect concerns.
Both the panel recommendation and the FDA approval come after a large-scale publicity campaign was launched in October of last year, led by Sprout and other organizations promoting Flibanserin. The campaign entitled “Even the Score,” wrote on its website that “There are 26 FDA approved drugs to treat various sexual dysfunctions for men (41 if you count generics!), but still not a single one for women’s most common sexual complaints. Why do we fast track the approval of drugs like Viagra (1998) for men?” Still, LaMattina questions the efficacy of the drug compared to the cost. Although a month’s supply of Addyi costs roughly the equivalent of a month’s supply of Viagra or Cialis, roughly $400 per month, LaMattina notes that the male drugs do not have to be taken on a daily basis. He states that women will have to spend nearly $5,000 per year for a modest increase in sexual desire. LaMattina believes that the cost, plus the side effects, will lead to the drug’s declining popularity after an initial surge of women trying the product. It should be noted, however, that LaMattina is a former head of R&D for Pfizer, the maker of Viagra.
Sources:
CNN.com – Debra Goldschmidt
Forbes – John LaMattina
The Guardian – Jana Kasperkevic
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