AMAG, Palatin Say Both Phase 3 RECONNECT Studies Met Co-primary End Points

(RTTNews) - AMAG Pharmaceuticals, Inc. (AMAG) and Palatin Technologies, Inc. (PTN) said Monday that both Phase 3 RECONNECT studies (301, 302) of Rekynda, or bremelanotide, met co-primary end points and demonstrated significant improvement in key symptoms of hypoactive sexual desire disorder.

Rekynda is an investigational product being developed as a potential on-demand treatment for pre-menopausal women diagnosed with hypoactive sexual desire disorder or HSDD.

AMAG Pharma and Palatin Technologies said that additional results from the Phase 3 RECONNECT Studies of Rekynda were presented at the International Society for the Study of Women's Sexual Health or ISSWSH Annual Meeting in Atlanta, Georgia.

Both Phase 3 studies met their co-primary endpoints of improvements in desire, as measured by the Female Sexual Function Index - Desire domain (FSFI-D), and decrease in associated distress, as measured by the Female Sexual Distress Scale - Desire/Arousal/Orgasm (FSDS-DAO).

These results were previously reported in November 2016 by Palatin Technologies who sponsored the studies prior to entering into a licensing agreement with AMAG for the North American rights to Rekynda.

"We are very pleased that the Phase 3 study results showed robust and consistent efficacy across the co-primary and multiple secondary endpoints, indicating that Rekynda may be an effective option in increasing desire and decreasing distress associated with HSDD," said Julie Krop, chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG.