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AMAG Pharmaceuticals files US FDA application for female sexual disorder drug

AMAG Pharmaceuticals Inc. filed a new drug application with the U.S. Food and Drug Administration for bremelanotide to treat hypoactive sexual desire disorder in premenopausal women, the most common type of female sexual dysfunction.

The disorder, which affects about 12 million women in the U.S., is characterized by low sexual desire and distress that is not attributable to existing medical, pharmacologic, psychiatric or relationship issues.

AMAG's application is backed by the results of two phase 3 studies in which patients treated with the drug experienced improved sexual desire and reduced distress.

Waltham, Mass.-based AMAG acquired the North American rights to develop and commercialize bremelanotide from Palatin Technologies Inc. in 2017.

Palatin Technologies will receive up to $80 million from AMAG upon achieving certain regulatory milestones, including acceptance of the application by the FDA. The agreement also includes up to $300 million sales milestones payments as well as royalties on net sales.

Palatin, which has granted additional licenses for bremelanotide in South Korea and China, is looking to enter similar agreements in other countries.