What is Rekynda?
Our lead product in late stage development is Rekynda, 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 Rekynda involves helping to activate internal pathways in the brain involved in the body’s normal sexual responses.
Rekynda 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 Rekynda as an as needed treatment for premenopausal women with HSDD, monitor side effects and collect information that will allow Rekynda to be used safely.
How is Rekynda Used?
Rekynda 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 Rekynda by pressing the autoinjector against their thigh or abdomen – the autoinjector does the rest.
Women will not have to take Rekynda on a daily basis. Rekynda is used only as needed prior to anticipated sexual activity.
What are Clinical Trial Results with Rekynda?
We completed our Phase 3 Reconnect Studies in August 2016, and announced top-line (preliminary) results in 4Q2016. Both Phase 3 Reconnect Studies of Rekynda 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.