Sprout Pharmaceuticals has resubmitted flibanserin, its twice-rejected, once-daily non-hormonal pill for hypoactive sexual desire disorder in premenopausal women, to the US Food and Drug Administration.
Sprout acquired flibanserin from Boehringer Ingelheim in 2011 after it was rejected by the FDA the year before. Despite being resubmitted in June 2013 with additional safety and efficacy data, the agency issued another complete response letter five months later, citing side effects.
After appealing that decision, Sprout is trying again, having completed Phase I studies (one pharmacokinetic, one driving), following a request by the FDA. Chief executive Cindy Whitehead said that the agency “has devoted significant resources to understand HSDD and the need for medical treatment”.
She added that the FDA’s “efforts to bring together panels of patients and clinical experts will prove to be a significant step in bringing about a solution for women with HSDD to market. This year, I am optimistic that women and their partners affected by the life impact of HSDD will have their first potential medical solution”.
Sprout claims that in three Phase III trials, flibanserin, a multifunctional serotonin agonist antagonist, has demonstrated a statistically significant difference compared to placebo on three primary endpoints – an increase of sexual desire, a decrease in distress from the loss of desire and an increase in the frequency of satisfying sex.
Whether the FDA is convinced by the latest refiling of flibanserin, often referred to as the ‘pink pill’ or ‘female Viagra’, remains to be seen. A decision is expected in six months.
