WASHINGTON -- A pill to treat low sexual desire in women may gain another chance at approval this year after an agreement between U.S. regulators and the drug's maker.
The FDA asked closely held Sprout Pharmaceuticals for three small studies on its desire drug flibanserin, the Raleigh, N.C.-based company said Tuesday in a statement. Sprout had appealed the agency's rejection last year of the therapy, which would be the first product for the disorder.
The FDA suggested Sprout study whether flibanserin may impair driving, as a side effect of the drug is sleepiness.
Sprout is seeking approval of flibanserin to treat female hypoactive sexual desire disorder, a condition of low libido that causes stress. The FDA asked for Phase 1 trials, which have at most 50 patients, instead of a new Phase 3 trial, which can require hundreds or thousands of volunteers and take years.
The company said it expected to resubmit its application for flibanserin's approval by the third quarter of the year. Three phases of clinical trials are usually required for U.S. regulatory approval of a new drug. -- Bloomberg News