A leading drug candidate for low sexual desire in women hasn't gotten approved for use in the United States, but the company backing it isn't giving up. Sprout Pharmaceuticals announced Tuesday that the U.S. Food and Drug Administration gave the company "clear guidance" on "the path forward" for its drug to treat low libido in women, called flibanserin. The FDA had rejected an application to approve the drug last year, which Sprout appealed. "The FDA has requested that Sprout complete two additional Phase I drug interaction studies and a Phase I driving simulator study," Sprout said in a statement. Such studies will look at different enzyme pathways and investigate whether the drug's side effects would impair driving.
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Flibanserin is a drug that showed positive results in clinical trials
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The FDA has declined to approve this drug
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The drug's promoters have appealed that decision
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The FDA requested more study of the drug
A smaller operation, @placeholder, took over work on the drug in 2011, and resubmitted an application with 14 new clinical studies, encompassing data on more than 3,000 new patients, according to the company.