FDA approves drug for loss of sexual desire in premenopausal women

(Reuters) – The U.S. Food and Drug Administration on Friday approved Palatin Technologies Inc and Amag Pharmaceuticals Inc’s drug to restore sexual desire in premenopausal women.

The therapy, Vyleesi, is the latest effort to come up with a treatment that some have dubbed a “female Viagra,” most of which have failed. Analysts have said that a drug that safely and effectively treats loss of sexual desire in women could eventually reach annual sales approaching $1 billion.

Vyleesi, chemically known as bremelanotide, works by activating pathways in the brain involved in sexual desire and response, helping premenopausal women with hypoactive sexual desire disorder (HSDD).

The drug will compete with Sprout Pharmaceuticals’ Addyi, a once daily pill that was approved for HSDD in 2015 with a warning restricting alcohol use when on the medication.

Vyleesi is seen as having several advantages over Addyi, including tolerable side effects, rapid-acting nature, and not having to take it every day, according to analysts.

The drug is administered as a shot into the abdomen or thigh using an auto-injector at least 45 minutes before anticipated sexual activity.

The FDA recommends not more than one dose within 24 hours or more than eight doses per month, and advises patients to discontinue the treatment if they do not see an improvement in libido after eight weeks.

The drug was developed by Palatin and Amag holds exclusive North America sales rights. It will pay Palatin $60 million upon approval plus additional payments for certain sales milestones and royalties.

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

Palatin’s shares jumped 44% to $1.93, while Amag shares rose 11.5% after the bell.