Therapy Areas: Central Nervous System
Palatin awarded US FDA approval for Vyleesi (bremelanotide injection) NDA for HSDD in premenopausal women
24 June 2019 -

Biopharmaceutical company Palatin Technologies Inc (NYSE American: PTN) reported on Friday the receipt of marketing approval from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for Vyleesi (bremelanotide injection) for the treatment of premenopausal women with acquired, generalised hypoactive sexual desire disorder (HSDD), the most common type of female sexual dysfunction in the US.

The companies added Vyleesi is approved for the treatment of premenopausal women with acquired, generalided hypoactive sexual desire disorder (HSDD). The prefilled Vyleesi autoinjector pen is self-administered into a woman's abdomen or thigh at least 45 minutes before anticipated sexual activity and can be taken at any time of day.

In conjunction, Palatin acquired the license to Vyleesi from AMAG.

Additionally, AMAG is expected to make Vyleesi commercially available in September 2019 through select specialty pharmacies.

Under a prior agreement with AMAG, Palatin is entitled to receive USD60m upon regulatory approval by the US FDA, tiered royalties on net sales ranging from high single-digit to low double-digit percentages as well as sales milestones based on escalating annual net sales thresholds, the first of which is USD25m.

According to the companies, Vyleesi is the first US FDA-approved product for the treatment of premenopausal women who experience distress or interpersonal difficulty due to low sexual desire. Vyleesi is believed to bind to melanocortin receptors in the central nervous system that are thought to be associated with sexual function.

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