‘Female Viagra’ approved by US FDA, but with strong warning
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THE first drug to treat low sexual desire in women has won approval from US health regulators, 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 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 professionals and pharmacies due to 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 in a statement.
“It validates (and) legitimizes female sexuality as an important component of health.”
But Public Citizen, a consumer watchdog group that testified against the drug earlier this year, predicted that Addyi will be pulled from the market within a few years because of “serious dangers to women, with little benefit” to them. “Unfortunately, we haven’t heard the last of this drug.”
The FDA had twice rejected the Raleigh, North Carolina-based firm’s drug. But the latest decision comes after an advisory panel concluded in June it should be approved with strict measures in place to ensure patients are fully aware of the risks.
Sprout officials could not be reached for comment.
The news sent shares of Palatin Technologies , which is creating a rival drug for HSDD, up about 30 percent to US$1.21 in extended trade.
Palatin said its drug, if approved, would only be taken as needed, not on a daily basis like Addyi, thereby providing women “greater control and flexibility.”
Unlike Viagra, which affects blood flow to the genitals, Addyi is meant to activate sexual impulses in the brain. It is similar to a class of other drugs known as selective serotonin reuptake inhibitors, or SSRI’s, that include antidepressants such as Prozac.
Addyi will come with a “boxed warning” about side effects, including among people with liver impairment or who take Addyi with alcohol or with medicines known as CYP3A4 inhibitors that include certain steroids.
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