US regulatory advisers have backed the approval of an experimental pill to treat low sexual desire in women.
If approved by the Food and Drug Administration, it will be the first such drug to be sold in the United States, Bloomberg reported Friday.
A panel of FDA advisers voted 18-6 Thursday that the benefit of Sprout Pharmaceuticals Inc.’s flibanserin outweighs the risk of fainting caused by the treatment.
The advisers said flibanserin should only be approved on the condition that prescribers are certified, to minimize the drug’s risks, including its interaction with alcohol.
“I think we all wish it was a drug that was a better one, but overall very modest benefit outweighs the real risk associated with it” when combined with a risk management plan, Amy Whitaker, a panel member and assistant professor in the University of Chicago’s department of obstetrics and gynecology, was quoted as saying.
The FDA previously rejected the pill, which closely held Sprout proposes to call Addyi, in 2013 because of its modest effect.
In a report Tuesday, FDA staff raised concerns about a possible danger caused by women fainting when they took the drug.
Whitaker’s comments echoed many who voted in favor of the drug because it will be the first, even though they don’t think it will be as helpful as many would like.
While men have popular drugs such as Cialis and Viagra to help with their sexual performance, there is no equivalent for women.
Women in three clinical trials who took flibanserin recorded a median increase of 0.5 to one more satisfying sexual events each month than those who got a placebo.
The women began the trials experiencing two to three satisfying sexual events a month.
Flibanserin acts on neurotransmitters that communicate information throughout the brain and body and can affect mood.
The drug lowers the level of serotonin in the brain and boosts the amounts of dopamine and norepinephrine.
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