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Dec 12, 2013

Sprout Pharma Appeals 2nd CRL for Female Sexual Dysfunction Drug

  • Sprout Pharmaceuticals is appealing a Complete Response Letter (CRL) sent by the FDA concerning the company’s re-submitted New Drug Application (NDA) for flibanserin, a once-daily treatment for the most common form of female sexual dysfunction.

    FDA accepted the formal dispute resolution request on December 3. Based on agency guidance, Sprout said it expects a response from the FDA on the appeal during the first quarter of 2014.

    The agency sent its CRL in response to Sprout’s re-submission in June of its NDA for flibanserin, which is designed to treat Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. Sprout noted that the re-submission included 14 new clinical studies with data on more than 3,000 new patients – an expansion of 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 FDA “provided the company with a more complete understanding of its review of the NDA,” the company said in a statement.

    Flibanserin was developed by Boehringer Ingelheim, which failed to win approval for the drug candidate when FDA’s Advisory Committee for Reproductive Health Drugs in 2010 voted 10-1 against recommending approval. The advisory panel contended that flibanserin had not shown a significant increase in women’s sexual desire compared to placebo, and had shown significant side effects that included depression and dizziness. FDA responded by sending its first CRL concerning the drug.

    Last year Boehringer Ingelheim sold rights to flibanserin to Sprout, which was founded in 2011 and says it is wholly focused on women’s sexual health. Within weeks, Sprout raised $20 million from 59 individual investors through an equity offering.

    Sprout also published results of a Phase III trial in the Journal of Sexual Medicine, “Study 511.147,” in which nearly 1,100 premenopausal women (mean age: 36.6 years) with HSDD showed statistically significant improvement following treatment with flibanserin 100 mg once daily at bedtime or placebo for 24 weeks. Co-primary end points were the change from baseline to study end in number of satisfying sexual events and increases in desire as measured by the Female Sexual Function Index desire domain score.

    Flibanserin is one of several drugs being positioned by their developers as a “female Viagra,” with the goal of at least duplicating the male sexual dysfunction pill’s blockbuster sales in its early years.



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