Sprout Pharmaceuticals - Sprout Pharmaceuticals, Inc. - Committed to the treatment of female sexual dysfunction (FSD)
FDA Requests 3 New Studies On Pill Aimed At Boosting Female Sex Drive.
FDA asks for more trials of Sprout's drug for low female libido | Reuters
The U.S. Food and Drug Administration has denied an appeal by Sprout Pharmaceuticals to approve its experimental drug for low female sexual desire but offered a potential pathway to approval.
The FDA has asked for three additional studies, two to test the drug's interaction with other drugs, and a third to simulate driving since nearly 10 percent of women in clinical trials became sleepy while taking the drug, flibanserin.
The FDA rejected flibanserin last year saying its effects were "modest" and did not outweigh side effects such as dizziness, nausea and fatigue.
FDA Requests 3 New Studies On Pill Aimed At Boosting Female Sex Drive.
FDA asks for more trials of Sprout's drug for low female libido | Reuters
The U.S. Food and Drug Administration has denied an appeal by Sprout Pharmaceuticals to approve its experimental drug for low female sexual desire but offered a potential pathway to approval.
The FDA has asked for three additional studies, two to test the drug's interaction with other drugs, and a third to simulate driving since nearly 10 percent of women in clinical trials became sleepy while taking the drug, flibanserin.
The FDA rejected flibanserin last year saying its effects were "modest" and did not outweigh side effects such as dizziness, nausea and fatigue.
