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 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 because a side effect of the drug is sleepiness. The agency based its original rejection of the pill on what it called a modest effect.
“We are encouraged by the FDA’s response and view it as a significant step toward the approval of flibanserin,” Cindy Whitehead, president and chief operating officer of Sprout, said in the statement.
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 will involve at most 50 patients, instead of a new Phase 3 trial on the drug’s benefit, 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.
In clinical trials, Sprout’s pill almost doubled the increase women saw in satisfying sexual experiences over a month’s time compared with patients who took a placebo, the company said.
A group of women’s advocates met with Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, last month to discuss the lack of parity between treatments for men and women with low libido or other sexual disorders. The FDA has approved 24 treatments for male sexual dysfunction. The group called the effect of flibanserin “not modest but meaningful” in a follow-up letter to Woodcock.
“It is time to label and approve the first drug for the treatment of the most common form of female sexual dysfunction,” wrote the eight advocates from groups including the National Organization for Women and Society for Women’s Health Research. “What a remarkable opportunity this is for the FDA to break down an important barrier and long standing discrepancy.”
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