Female Libido Pill Continues to Stimulate Interest

Female Libido Pill Continues to Stimulate Interest
Female Libido Pill Continues to Stimulate Interest

Sprout Pharmaceuticals has announced that they will resubmit the New Drug Application (NDA) for flibanserin by the third quarter. Flibanserin is a novel non-hormonal once-daily treatment for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

The FDA issued a Complete Response Letter (CRL) in October 2013 regarding Sprout's NDA for flibanserin and requested additional Phase I studies to investigate potential drug interactions and driving impairment. A reported 9.8% of women reported somnolence (sleepiness) while taking flibanserin 100mg. The company currently has data on over 11,000 patients. The FDA previously rejected Sprout's application for flibanserin because the drug showed only a modest effect in their risk/benefit evaluation.

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, not better accounted for by a medical, substance-related, psychiatric, or other sexual condition. It is thought to include a mix of social, psychological, and biological factors.

Currently, there is no FDA-approved treatment for HSDD in women. Flibanserin is thought to work by correcting neurotransmitter imbalance levels by increasing dopamine and norepinephrine, while decreasing serotonin.

For more information call (919) 882-0850 or visit SproutPharma.com.

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