Flibanserin interacts with brain chemicals, upping the amounts of specific neurotransmitter chemicals

By Alex Heigl
Updated August 19, 2015 12:25 PM
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Credit: Allen G. Breed/AP

The Food and Drug Administration has approved flibanserin, the first drug in the United States aimed at treating low libido in women. The move follows a vigorous campaign by the drug’s manufacturers.

Though referred to as “female Viagra,” the two drugs work in different ways. Viagra increases blood flow to the genitals, while flibanserin increases levels of neurotransmitters dopamine and norepinephrine in the brain.

Researchers aren’t entirely sure why flibanserin works the way it does. (It was initially developed as an anti-depressant.)

Because of these concerns, the FDA has placed a number of restrictions on the drug. The agency is asking flibanserin’s maker, Sprout Pharmaceuticals, which is marketing the drug under the brand name Addyi, to develop and implement special training for doctors and pharmacists before they can dispense the drug. Once they have, they’re required to carefully track problems that may develop in patients.

The FDA had already twice rejected the drug, presumably because of its side effects, which include sudden fainting – risky in any situation, but especially for drivers – and the way it interacts with alcohol. (The FDA recommends avoiding alcohol entirely with flibanserin.)

This is the first drug approved to treat lack of sexual desire in women, something stressed by Sprout’s public relations campaign, named “Even the Score.” But it faced vocal opposition along the way: “This is a product that is neither very effective nor particularly safe,” former FDA official and current George Washington University professor Dr. Susan Wood told NBC News.

“It won’t benefit many women and at the same time the approval comes with a lot of restrictions, setting a precedent that a drug for women’s sexual health has to be treated in a very special way,” she added.

Sprout aims to have Addyi available by October, and the drug will be priced competitively with Viagra. With insurance coverage, the drugmaker says it will end up costing most patients $30-$75 a month.