In an 18-to-6 vote at the FDA joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee, flibanserin was recommended for approval to treat hypoactive sexual desire disorder in premenopausal women.
The non-hormonal drug flibanserin (ADDYI, Sprout Pharmaceuticals), studied for efficacy in more than 11,000 women, gained the recommendation for approval with the requirement that certain risk management options beyond labeling be implemented, according to a news release.
“Yesterday’s vote is going to have a huge impact on the entire future of this field,” Sheryl Kingsberg, PhD, a clinical psychologist and chief of behavioral medicine at University Hospitals Case Medical Center, Cleveland, told Healio.com. “Their vote really was a message to anybody doing any research in this field as to whether or not they could move forward.”
Kingsberg, an investigator in flibanserin trials involving both premenopausal and postmenopausal women, delivered what she called “a necessary informational opening” at the meeting on behalf of Sprout that conveyed the unmet medical need in approximately 16 million women with hypoactive sexual desire disorder (HSDD).
“The advisory committee had very diverse background, therefore it was important that they developed a common understanding of the profound impact of this condition on women and what women actually want from a treatment,” Kingsberg said.
HSDD is the most commonly reported form of female sexual dysfunction and characterized by deficiency or absence of desire for sexual activity, which causes marked distress.
Testimony from patients in the open forum made an impact on the joint committee, according to Kingsberg. “They learned that modest benefit, which is what they perceived from the clinical trials, was actually very meaningful to these patients.”
Three 6-month, randomized, double-blind, placebo-controlled, parallel-group phase 3 trials involving premenopausal women (mean age = 36 years) have shown flibanserin offers statistical improvements on three key endpoints: sexual desire, distress from the loss of sexual desire; and increase in the frequency of satisfying sex.
“In these kinds of trials looking at sexual desire, the endpoints may not show a huge number change, but that’s not what women are looking for,” Kingsberg said. “They’re looking for some restoration of their desire.”
Kingsberg underscored that trial results that appear to demonstrate, as one advisory committee called, “minimal” change actually represent “meaningful” change for women.
“With the idea of satisfying sexual events as a primary endpoint, those who are not in the field might think it’s not a huge number of events that increase,” Kingsberg said. “But women don’t really think about desire in terms of activity as much as they think about it in terms of wanting or the motivation to engage in intimacy with their partner.”
The safety of flibanserin has also been proven in trial data from over 8,500 women, with over 1,000 of those women exposed to treatment for at least 1 year, according to the release. The majority of side effects were mild, with dizziness, nausea and sleepiness reported most commonly.
Although the FDA is not required to accept the recommendation given by the committee, the agency considers it as part of the new drug application review. If approved, flibanserin would be the first authorized to treat HSDD.
“It has been such a long road,” Kingsberg said. Research on flibanserin as a treatment for HSDD has been underway for about 10 years, with phase 3 trials over the last 5.
Flibanserin has an anticipated Prescription Drug User Fee Act date of August 18, according to a Sprout representative.
“We are certainly hopeful the FDA will take the committee’s advice and approve in August,” she said. “If you meet all those endpoints and have good efficacy and risk-benefit profile, and you still don’t get approved, that really sends a message that nothing will get approved.” – by Allegra Tiver
Disclosure: Kingsberg reports being a consultant for Apricus, Emotional Brain, Metagenics, Novo Nordisk, Palatin, Pfizer, Shionogi, Sprout, SST, Teva, TherapeuticsMD and Trimel.