Sprout Pharmaceuticals announced that it has resubmitted its New Drug Application (NDA) to the Food and Drug Administration (FDA) for flibanserin, a multifunctional serotonin agonist antagonist (MSAA), for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.
The FDA had issued a Complete Response Letter (CRL) for flibanserin in 2013. In response to the CRL, Sprout conducted a Phase 1 pharmacokinetic study and a Phase 1 driving study, which was included in the NDA resubmission.
Previously, flibanserin was evaluated in three pivotal Phase 3, randomized, double-blind, placebo-controlled, parallel-group North American studies of premenopausal women with a mean age of 36 years. In all trials, flibanserin demonstrated a statistically significant difference compared to placebo on three key endpoints: an increase of sexual desire; a decrease in distress from the loss of sexual desire; and an increase in the frequency of satisfying sex.
Flibanserin is an investigational, once-daily, non-hormonal drug and if approved would be the first and only post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist available for the treatment of premenopausal women with HSDD. Flibanserin may work by restoring prefrontal cortex control over the brain’s motivation/rewards structures enabling sexual desire to manifest. Specifically, flibanserin increases dopamine and norepinephrine while transiently decreasing serotonin in the brain’s prefrontal cortex, which may be accomplished by reduced glutamate transmission.
For more information visit SproutPharma.com.