What is Vyleesi™?
Vyleesi, the trade name for bremelanotide, is a novel melanocortin 4 receptor agonist under investigation to help restore a natural sexual desire in premenopausal women with HSDD. The mechanism of action of Vyleesi involves helping to activate internal pathways in the brain involved in the body’s normal sexual responses.
Vyleesi has been studied in more than 30 clinical trials with over 2,500 people. The Phase 3 Reconnect Studies were designed to confirm the effectiveness of Vyleesi as an on-demand treatment for premenopausal women with HSDD, monitor side effects and collect information that will allow Vyleesi to be used safely.
How is Vyleesi Used?
Vyleesi is given by subcutaneous injection under the skin using a single use autoinjector pen. There is no visible needle with the autoinjector. In Phase 3 clinical trials women administered Vyleesi by pressing the autoinjector against their thigh or abdomen – the autoinjector does the rest.
Women will not have to take Vyleesi on a daily basis. Vyleesi is used only as needed prior to anticipated sexual activity.
What are Clinical Trial Results with Vyleesi?
We completed our Phase 3 Reconnect Studies in August 2016, and announced top-line (preliminary) results in 4Q2016. Both Phase 3 Reconnect Studies of Vyleesi 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 was submitted in March 2018, with acceptance of the filing in June 2018. The PDUFA (Prescription Drug User Fee Act) goal date for completion of FDA review of the Vyleesi New Drug Application is June 23, 2019.