The FDA approves the drug for loss of sexual desire in women


(Reuters) – The American drug regulator on Friday approved the drug Palatin Technologies and Amag Pharmaceuticals to restore sexual desire in premenopausal women, the last attempt to propose a therapy that some have nicknamed "female Viagra".

PHOTO FILES: A view shows the headquarters of the Food and Drug Administration (FDA) in the United States in Silver Spring, Maryland, August 14, 2012. Photo taken August 14, 2012. REUTERS / Jason Reed

The therapy, Vyleesi, will compete in a market that has seen previous attempts fail. Analysts have claimed that a drug that treats loss of sexual desire in women safely and effectively could eventually reach annual sales of around $ 1 billion.

Palatin shares rose 44% to $ 1.93, while Amag's shares rose 11.5% after the market.

Vyleesi, chemically known as bremelanotide, activates the brain pathways involved in sexual desire, helping premenopausal women with hypoactive sexual desire disorder (HSDD).

The drug will compete with Sprout Pharmaceuticals' Addyi, a once-daily pill approved for HSDD in 2015 with a warning that limits the use of alcohol during treatment. It will be available from September through some pharmacies.

Addyi was approved under intense pressure from the advocacy groups, despite a review by scientists from the Food and Drug Administration (FDA) that it found it to be ineffective and probably unsafe.

Vyleesi, which does not limit the use of alcohol, is seen as having many advantages over Addyi, including tolerable side effects, fast-acting nature and not having to take it every day, according to analysts.

The side effects reported during clinical trials included mild to moderate nausea that lasted no more than two hours and mostly occurred during the first three doses, Amag said. About 40% of patients in clinical studies experienced nausea.

The drug is administered as an abdomen in the abdomen or thigh using an autoinjector at least 45 minutes before the intended sexual activity, with the FDA advising patients not to take more than one dose within 24 hours or more than eight doses per month.

The drug was developed by Palatin and Amag holds the exclusive sales rights of North America. The Palatin will receive $ 60 million from Amag for approval, as well as additional payments for certain key selling points and royalties.

HSDD affects about 6 million women in the United States, but few seek or receive care.

Ami Fadia, SVB Leerink analyst, said there would be a need for more direct-to-consumer advertising through social media, which could help build awareness about HSDD.

"These women are simply suffering in silence and therefore the market does not really exist today," said Amag CEO William Heiden.

Ladenburg analyst Thalmann Michael Higgins predicts that Vyleesi sales could reach $ 732 million by 2030.

Reporting of Saumya Sibi Joseph in Bengaluru; Editing by Bill Berkrot and Shounak Dasgupta

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