‘Female Viagra’ gets approval

The first drug to treat low sexual desire in women won approval from US health regulators on Tuesday, but with a warning about potentially dangerous low blood pressure and fainting side effects, especially when taken with alcohol.

The US Food and Drug Administration (FDA) said the pink pill, to be sold under the brand name, Addyi, and made by privately-held Sprout Pharmaceuticals, will only be available through certified and specially trained health-care professionals and pharmacies because of its safety issues.

Addyi, whose chemical name is flibanserin, is designed for premenopausal women whose lack of sexual desire causes distress. The condition is formally known as hypoactive sexual desire disorder, or HSDD. The drug needs to be taken daily.

Addyi has been nicknamed the “female Viagra” even though it does not work like Pfizer Inc’s blockbuster Viagra pill for men that, in 1998, became the first approved drug for erectile dysfunction.

“This is the biggest breakthrough in women’s sexual health since the advent of the Pill for contraception”, The National Consumers League said.

But Public Citizen, a consumer watchdog group, predicted that Addyi would be pulled from the market within a few years because of “serious dangers” to women.

The FDA had twice rejected the North Carolina-based firm’s drug. But the latest decision comes after a panel concluded in June it should be approved with strict measures in place to ensure patients were fully aware of the risks.

The news sent shares of Palatin Technologies, which is creating a rival drug for HSDD, up about 30 percent to $1.21 (R15) in extended trade.

Palatin’s experimental treatment, called bremelanotide, is now in late-stage trials and works differently from Addyi.

It attempts to activate certain brain pathways. Palatin yesterday said its drug, if approved, would only be taken as needed.

Women who took Addyi in a clinical study had an increase of about one sexually satisfying event per month compared with those taking a placebo.

Addyi will come with a prominent “boxed warning” about side effects.

Originally developed by Germany’s Boehringer Ingelheim under its chemical name flibanserin, it was first rejected by the FDA in 2010. Sprout acquired the drug and resubmitted the application. In 2013, the FDA rejected it again.

The rejection sparked a lobbying campaign by Sprout, aided by some women’s groups who accused the FDA of gender bias because it had approved Viagra for men.

The FDA approved Addyi despite a rocky relationship with the founders of Sprout.

The chief executive of Sprout, Cindy Whitehead, co-founded the company with her husband, Robert Whitehead, in 2011 after selling another small drugmaker they had founded called Slate Pharmaceuticals which had received repeated warnings from the FDA.

Slate marketed an implantable testosterone pellet for men with low levels of the male sexual hormone, called Testopel.

In one FDA warning letter, issued on March 24, 2010, the FDA said Slate had improperly inferred on its Testopel website and in a video that the testosterone product could help patients with depression, erectile dysfunction, diabetes and HIV.

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