USL255 PREVAILs in Phase III epilepsy, FDA to review NDA

Upsher-Smith Laboratories Inc. (Maple Grove, Minn.) said on Wednesday that once-daily USL255 as adjunctive therapy met the primary endpoint in the Phase III PREVAIL trial, and that FDA accepted for review an NDA for USL255 as adjunctive treatment of epilepsy in patients with refractory partial-onset seizures. In the trial, USL255 reduced from baseline weekly partial-onset seizure frequency during the titration plus maintenance phase vs. placebo (p<0.001). The double-blind, international trial enrolled more than 200 epileptic patients. Upsher-Smith, which has an SPA from FDA for the trial, said the data will be submitted for presentation at the American Epilepsy Society meeting in December. ...