Female Sexual Disorder Drug Appears Effective in Two Phase 3 Studies

Two Phase 3 trials of 600 randomized patients were conducted
Two Phase 3 trials of 600 randomized patients were conducted

AMAG pharmaceuticals and Palatin Technologies have entered into an agreement for the exclusive North American rights to develop and commercialize Rekynda (bremelanotide), an investigational drug to treat hypoactive sexual desire disorder (HSDD).

Two Phase 3 double-blind, placebo-controlled studies of Rekynda, delivered subcutaneously via an auto-injector pen, reached their primary endpoint of improvement in desire and decrease in distress associated with low sexual desire, as measured by patient reports. Each trial consisted of more than 600 patients randomized in a 1:1 ratio to either the treatment arm or placebo with a 24 week evaluation period. The most frequent adverse events were nausea, flushing, and headache; Rekynda has no known alcohol interactions. 

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Rekynda is believed to possess a novel mechanism of action, activating endogenous melanocortin pathways involved in sexual desire and response.

The new drug application (NDA) for Rekynda is expected to be filed in early 2018, and approval is anticipated by early 2019.

“As a potentially safe, on-demand treatment with a fast onset of action, Rekynda could offer an important therapeutic alternative for pre-menopausal women suffering from HSDD,” said Carl Spana, PhD, CEO of Palatin Technologies.

HSDD is characterized by low sexual desire that causes marked distress. According to 2008 study published in Obstetrics & Gynecology, HSDD affects approximately 15 million women in the U.S.

For more information visit Palatin.com.