Regulators OK injectable med to bolster women's sex drive

24 Juin, 2019, 06:23 | Auteur: Yves Courtet
  • AMAG's auto-injector Vyleesi just won FDA nod to rival Sprout's Addyi in premenopausal women with hypoactive sexual desire disorder

Food and Drug Administration on Friday gave its approval to Vyleesi, a drug to treat women with low sexual desire.

The drug is injected under the skin of the abdomen or thigh at least 45 minutes prior to a sexual encounter, although the best timeframe for dosing could vary from user to user.

Friday's decision for Waltham, Massachusetts-based drugmaker Amag Pharmaceuticals marks only the second time regulators have approved a drug for the condition. "These women have suffered significantly, pretty much in silence, for a stigmatised condition, and many of them have not known that it's a treatable medical condition". It will be used to treat premenopausal women with a hypoactive sexual desire disorder, which is defined by a persistent lack of interest in sex, causing stress. Medications for men experiencing erectile dysfunction arrived on the market two decades ago.

But these treatments for women have provoked controversy.

Bremelanotide is not the first drug to be approved for this goal. But some opponents argued its risks outweighed its benefits. Vyleesi, which does not restrict alcohol use, 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. About 40% of patients in the clinical trials experienced nausea, most commonly with the first Vyleesi injection, and 13% needed medications for the treatment of nausea.

Vyleesi is the second treatment for HSDD cleared for marketing in the USA, following the pill Addyi, which was approved in 2015.

"Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it's more hard to treat", Dr. Nicole Cirino, co-director of the Menopause and Sexual Therapy Clinic at Oregon Health and Science University's Center for Women's Health, told CNN. It is developed by Palatin Technologies, which granted exclusive licensing rights to Amag Pharmaceuticals.

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Vyleesi, like Addyi, probably won't be overprescribed, Cirino added. Addyi, made by Sprout Pharmaceuticals, never took off commercially, in large part because of a black-box safety warning that prohibited women from drinking alcohol before taking it.

Vyleesi's demonstrated increases in reported desire, measured on a five-point scale, are small.

WASHINGTON-U.S. women will soon have another drug option created to boost low sex drive: a shot they can give themselves in the thigh or abdomen that raises sexual interest for several hours.

That's because, she said, women with low sex drive continue to have sex with their partners, they just don't enjoy it. "The problem is, they're distressed about having that sex that they are having".

Some drug-industry critics questioned whether Vyleesi was the latest example of a company promoting a pharmaceutical solution for something that is, in reality, far more complex.

"I think it's worth noting what's an acceptable level of libido is socially influenced", said Dr Adriane Fugh-Berman, a professor in the department of pharmacology and physiology at Georgetown University Medical Center who studies pharmaceutical marketing.


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