“Female Viagra” One Step Closer to Market

We're one step closer to having a drug that's been described as "female Viagra."

A U.S. Food and Drug Administration (FDA) advisory panel yesterday voted to recommend that the federal agency approve a drug intended to increase low sexual desire in women. Panel members, however, also said that approval was contingent on a "risk management program" for the medication, called flibanserin. That would include the creation of a patient registry, safety studies and a warning against taking the drug with alcohol.

The benefits of the drug are marginal, but can be helpful for some women, according to the panel. There also can be potentially serious side effects, such as fainting at unpredictable times, and low blood pressure.

Fibanserin works differently from Viagra. It does not increase blood flow; instead it works on a woman's brain. The drug, which needs to be taken daily, was initially developed as an antidepressant, but is now designed to be taken daily to help females with low libido. Concerned for the safety of the dozens of women who pleaded to the panel, the advisory board also recommended that physicians be certified to prescribe the drug, and that pharmacies be required to confirm certification before a prescription can be made. The pill's proposed trade name is Addyi,

The drug has been rejected twice before by the FDA. Yesterday's approval by the advisory panel comes after months of women’s advocacy groups accusing the FDA of rejecting the drug based on gender bias. Agency officials have denied that.

The FDA could approve the drug by the end of the summer.

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Sourced from: Reuters, U.S. FDA panel supports female libido drug with risk management plan