What is Vyleesi™ (bremelanotide)?
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 as needed 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.
Vyleesi is used only as needed prior to anticipated sexual activity. Women will not have to take Vyleesi on a daily basis.
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.
In November 2018 we disclosed that the FDA requested that additional data be generated from a small Phase 1 study with premenopausal volunteers assessing 24-hour ambulatory blood pressure with short term daily use of Vyleesi. Palatin and AMAG, our exclusive North American licensee, believe that this study can be conducted and data submitted prior to the currently schedule PDUFA goal date. Although AMAG’s discussions to date with the FDA are preliminary, and AMAG will continue to have further discussions with the FDA on this matter. AMAG believes that this submission of additional data could cause a delay of the potential approval of Vyleesi by three to six months.