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Home / Health / FDA Approves Drug for the Loss of Sexual Desire in Women – bdnews24.com

FDA Approves Drug for the Loss of Sexual Desire in Women – bdnews24.com



The therapy, Vyleesi, will survive on a market where earlier attempts failed. According to analysts, a drug that safely and effectively treats the loss of sexual desire in women could reach an annual turnover of about $ 1 billion.

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

Vyleesi, chemically known as bromelanotide, activates the sexual desire pathways in the brain and helps women in premenopause with hypoactive sexual desire disorder (HSDD).

The drug will compete with Sprout Pharmaceuticals & # 39; Addyi, a once-daily pill, for HSDD in 2015 with a warning to limit alcohol intake when taking medications. It will be available from September in selected pharmacies.

Addyi was heavily pressured by interest groups, though scientists at the Food and Drug Administration (FDA) considered it minimally effective and potentially unsafe.

Vyleesi, According to analysts, alcohol use has several benefits over Addyi, including tolerable side effects, rapid action and the fact that it does not need to be taken daily.

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

The drug is injected into the abdomen or thigh at least 45 minutes before the anticipated sexual activity with an auto-injector. The FDA advises patients not to take more than 20 minutes a dose within 24 hours or more than eight doses each month.

The drug was developed by Palatin and Amag owns the exclusive sales rights for North America. Palatin receives $ 60 million from Amag for approval and additional payments for certain milestones and royalties.

HSDD affects about 6 million women in the US, but few seek or receive treatment.

said Ami Fadia, an analyst at SVB Leerink We need more direct mail through social media, which could help raise awareness of HSDD.

"These women only suffer from silence, and that's why the market does not really exist today," said Amag CEO William Heiden.

Ladenburg-based Thalmann analyst Michael Higgins predicted that Vyleesi's sales could reach 732 million US dollars by 2030.


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