Sprout Pharma appeals FDA Complete Response on flibanserin for Hypoactive Sexual Desire Syndrome
Sprout Pharmaceuticals announced that it has received and appealed the 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.
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