In the next few weeks, the FDA will rule again on a prescription treatment for female sexual dysfunction. This is the third time the FDA has considered Sprout Pharmaceuticals' drug flibanserin, which has been rejected twice. This time, however, it has its best chance yet of getting approved, having already gained an FDA advisory panel nod in June.
But why now? What has changed to make a "yes" more likely this time? First off, Sprout has completed three new Phase I studies designed to address concerns about flibanserin's interaction with other drugs and its effect on patients' ability to drive the morning after use.
A less concrete--but potentially significant--influence this time around, though, has been the voice of a persuasive advocacy group called "Even the Score." It's a coalition of women and healthcare groups founded in 2014 after the second rejection of flibanserin.
A spokeswoman for Even the Score said the advocacy group launched after 9 women's organizations met with the FDA to "discuss their concerns about the lack of treatment options for sexual dysfunction compared to men" and decided a formal effort was needed. Now 24 groups, including Sprout and fellow pharma Trimel Pharmaceuticals, are members.
Even the Score has worked diligently to raise awareness about the issue of female sexual dysfunction, especially the disparity in treatment options compared with the numerous drugs for males. Public relations efforts have included a nationwide petition, which was signed by 55,000 women, and encouraging people to write their Congress members. In March, 11 members of Congress co-signed a letter to the FDA indicating support for the approval of what they referred to as a resubmitted drug "which could become the first commercially available treatment of women's most common sexual complaint." They never named that drug, but it is clear the lobbying is for flibanserin.
"While Even the Score does not advocate for the approval of any individual drug, as the first HSDD [hypoactive sexual desire disorder] medical treatment in a pipeline that must be opened, the coalition believes that flibanserin deserves the Agency's fair consideration," said the Even the Score spokeswoman in an email. "Even the Score is about raising awareness of the gender disparity in FDA-approved drugs for sexual dysfunction and calling on the FDA to provide women with safe and effective options for treatment, just as men have today."
Sprout also weighed in by email: "As an industry sponsor, Sprout hopes that the Even the Score campaign succeeds in achieving its goals: educates and informs about women's sexual dysfunction and lack of treatment options; advocates for an option for women who are affected by HSDD and supports those women by providing an avenue to share their stories and stand together."
Sprout, which wants to market flibanserin as Addyi, is specifically looking for FDA approval to treat premenopausal women with HSDD. Sprout's email said that its support of Even the Score means it "has provided funding to help support development and management of the campaign, but does not directly contribute financially to the advocacy organizations supporting the campaign."
Another key difference this time around is that individual proponents were heard during the FDA advisory hearing. Women who took flibanserin as part of the research spoke about the positive impact on their lives. As The Washington Post reported, "after an afternoon of emotional testimony from women who suffer from low sexual desire, … the majority of committee members said that, with proper warning labels and education, the drug, even with a moderate benefit, should be made available to women who now have nothing."
Sprout "believes the last year has marked a wonderful progression of scientific evidence and HSDD condition understanding with the FDA efforts to put the patient voice at the center of it," the spokeswoman wrote. "… Sprout feels confident that the FDA will make a decision rooted in the science behind Addyi, based on the totality of the data presented to them, and in the best interest of the millions of women that suffer with the condition."