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ARTICLE | Company News

FDA panel rebuffs Clarus' testosterone

September 19, 2014 2:44 AM UTC

FDA's Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees voted against approval of Rextoro oral testosterone from Clarus Therapeutics Inc. (Northbrook, Ill.). The committees voted 18-3 that Rextoro's overall risk/benefit is insufficient to support approval as replacement therapy in testosterone-deficient men, and 12-8 that its efficacy evidence is insufficient. The PDUFA date is Nov. 3.

In June, Clarus said Rextoro met its primary efficacy endpoint in a Phase III trial, achieving mean serum testosterone concentrations in the normal range of 300-1000 ng/dL in 75% of patients. ...