FDA Accepts Appeal Filed through Formal Dispute Resolution Process
Raleigh, N.C., December 11, 2013 – Sprout Pharmaceuticals today announced that it has received and appealed the Food and Drug Administration’s (FDA) Complete Response Letter (CRL) for flibanserin through the Formal Dispute Resolution process. Flibanserin is an investigational, once-daily treatment for Hypoactive Sexual Desire Disorder, or HSDD, in premenopausal women. HSDD is the most commonly reported form of female sexual dysfunction.
The CRL was received in response to Sprout’s re-submission of the new drug application (NDA) for flibanserin earlier this year. Sprout’s resubmission included 14 new clinical studies with data on more than 3,000 new patients, expanding the number of subjects having completed clinical trials to more than 11,000, including more than 5,000 who were treated with flibanserin in Phase III efficacy studies. Sprout recently completed an end-of-review meeting in which the FDA provided the Company with a more complete understanding of its review of the NDA.
“Sprout strongly believes that it has satisfied the statutory requirements for approval of flibanserin,” said Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals. “In clinical trials, flibanserin has outperformed placebo with statistical significance and, importantly, women treated with flibanserin perceived their improvement to be clinically meaningful. What the Division characterizes as a modest effect in their risk/benefit evaluation, we see as meaningful effect on the hallmark characteristics of the condition. It is the basis of our dispute. It is true that flibanserin does not cause hypersexuality but by that definition, modest would be what we’re aiming for. Further, in the risk/benefit evaluation, we believe that the safety profile of flibanserin is similar to that of other approved drugs where effect was characterized as modest by the agency and can be managed through a combination of labeling and responsible product launch, including post-market assessments and communications. If approved, flibanserin could meet an important unmet medical need for women.”
The FDA accepted the formal dispute resolution request on December 3, 2013. Based on the Agency’s guidance, Sprout expects a response from the FDA on the appeal in the first quarter of 2014.
About the FDA’s Formal Dispute Resolution Process
The appeal was submitted in accordance with the Formal Dispute Resolution process that exists within FDA’s Center for Drug Evaluation and Research (CDER). Responses to CDER appeals are typically made within 30 to 60 days. FDA regulations provide a mechanism for those seeking regulatory approval of a drug product pursuant to an NDA to obtain formal review of any Agency decision by raising the matter with the supervisor of the employee who made the decision. The process exists to encourage open, prompt discussion of scientific (including medical) disputes and procedural (including administrative) disputes that arise during the drug development, NDA review, and post-marketing oversight processes.
About Hypoactive Sexual Desire Disorder
HSDD is the most commonly reported form of female sexual dysfunction. HSDD is defined as a persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty, and which is not better accounted for by a medical, substance-related, psychiatric (e.g., depression) or other sexual condition. The cause of HSDD is believed to involve a multitude of social, psychological and biological factors and may be attributed to a complex interplay of these factors.
Flibanserin is a novel, non-hormonal drug that has been studied in clinical trials for the treatment of HSDD in premenopausal and postmenopausal women. The application submitted to the FDA is for premenopausal women only at this time. Flibanserin is believed to work on key neurotransmitters, or chemicals, in the brain that affect sexual desire. More specifically, it is thought that flibanserin corrects an imbalance of levels of these neurotransmitters by increasing dopamine and norepinephrine (both responsible for sexual excitement) and decreasing serotonin (responsible for sexual inhibition). In clinical studies, flibanserin was evaluated for its ability to increase the frequency of satisfying sexual events, increase the intensity of sexual desire and decrease the associated distress women feel from its loss.
About Sprout Pharmaceuticals
Sprout Pharmaceuticals is passionate about women’s sexual health. With a breakthrough concept for women, the company “sprouted” out of Slate Pharmaceuticals in 2011. Based in Raleigh, NC, the company is focused solely on the delivery of a treatment option for the unmet need of millions of women with HSDD. Sprout is currently and initially pursuing the FDA approval of flibanserin to treat HSDD in premenopausal women, for which there is currently no FDA-approved treatment. www.sproutpharma.com