The FDA approves sex-drive pill, Addyi

Third time's the charm for Sprout Pharmaceuticals' flibanserin.

The FDA on Tuesday approved the controversial drug, now known as Addyi, as a treatment for premenopausal women with low sexual desire, a condition known as hypoactive sexual desire disorder. After being twice rejected by the agency when owned by Boehringer Ingelheim, Addyi is scheduled to finally find its way to pharmacy shelves by October 17.

A Sprout spokeswoman told MM&M that the drug will not be advertised on radio or television for the first 18 months following its approval—to assuage concerns that the drug will be overused—and the company plans to focus its marketing efforts on a professional audience rather than consumers.

The company plans to hire 200 sales representatives to reach 30,000 doctors—most of whom are obstetricians and gynecologists, but sales efforts will also target some psychiatrists and primary care physicians.

The Sprout spokeswoman declined to provide a price for Addyi but said the company will likely establish a monthly price that is similar to the monthly cost of other erectile dysfunction treatments, like Pfizer's Viagra. Nine Viagra pills typically run about $400 without insurance. The drugmaker also said it expects the drug will receive Tier 2 or Tier 3 formulary status with payers, meaning the co-pay would range from $30 to $75 per month for patients.

The drug will likely face significant obstacles in its uptake among consumers and physicians. The FDA approved Addyi with a risk evaluation and mitigation (REMS) strategy, due to the drug's side effects when taken in combination with alcohol, which include losing consciousness and a dramatic drop in blood pressure. Only doctors and pharmacies certified in the REMS program will be allowed to prescribe and sell Addyi.

Addyi's label will also be accompanied by a black box warning drawing attention to the drug's possible side effects when taken with alcohol. The FDA is requiring Sprout to undertake three “well-designed” studies to better understand the interaction between Addyi and alcohol.

Even the Score, an advocacy organization that pushed for Addyi's approval and has ties to Sprout, said in a statement Tuesday: “The FDA today chose to respect the science and stand with millions of American women by approving the first-ever medical treatment option for HSDD. Approval of flibanserin represents an enormous step forward for the one in ten women living with HSDD.”

A survey conducted by Treato, a social-media data-mining company, found that 80% of 700 female survey participants “would be willing to take a daily pill to improve low sex drive” and another 73% said they were “likely to discuss low sex drive with a doctor.”

But other organizations questioned the validity of the approval. “The FDA's decision to approve flibanserin as a treatment for women with hypoactive sexual desire [disorder] presents serious dangers to women, with little benefit, and recklessly disregards the worrisome risk information in the agency's briefing package to the advisory committees that met on June 4th,” consumer rights advocacy group Public Citizen said in a statement.

That FDA advisory committee voted 18-6 in June recommending approval of Addyi. In doing so, the majority of the committee agreed that the benefits of flibanserin outweigh the risks.

Since that vote, however, three members of the committee said they believe the recommendation was borne out of a “politically charged atmosphere.”

The authors questioned the objectivity of Even the Score. They wrote in JAMA that Even the Score was “initially created through the efforts of a consultant to flibanserin's manufacturer.”

Even the Score advocates for “gender equality” in access to treatments for sexual dysfunction—arguing that there are 26 approved medications for male sexual dysfunction but none for women. The FDA disputed that claim, saying there are no approved products for low sexual desire in men.The 26 medications the group cites include multiple formulations of testosterone.

The drug's efficacy also raised concern in the editorial, with the authors noting that only between 8% and 13% of women who took the drug during clinical trials reported an an improvement compared to the placebo, and that women who took flibanserin averaged 0.5 more “sexually satisfying events per month.”

The drug's trial design also came into question. The authors said Sprout's trial used more subjective measures than Boehringer Ingelheim's study. BI sold the drug to Sprout in 2012.

BI's two Phase-III trials tested the drug's effectiveness through the reported number of satisfying sexual events, while the Sprout-conducted trial used a more subjective measure: patient-reported outcomes claims. Sprout's safety trial, too—meant to evaluate the drug's effects in patients who drink alcohol—was comprised of 25 volunteers, but only two women.