We completed our Phase 3 Reconnect Studies in August 2016, and announced top-line (preliminary) results in 4Q2016. Both Phase 3 Reconnect Studies of bremelanotide for HSDD in premenopausal women met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments. A New Drug Application is targeted for submission to Food and Drug Administration in early 2018.
www.palatin.com/research-focus/.../phase-3-reconnect-studies/