Upsher-Smith gets promising results from phase-3 trial of epilepsy drug

MAPLE GROVE, Minn. — An experimental drug under development by Upsher-Smith Labs for epilepsy is able to reduce seizures in patients with mild to moderate side effects, according to results of a late-stage clinical trial announced Monday.

The drug maker presented results of the phase-3 "PREVAIL" trial of USL255 at the American Epilepsy Society's 67th Annual Meeting in Washington, which started Friday and ends Tuesday. USL255, an extended-release formulation of the drug topiramate, showed a significantly greater reduction in the frequency of weekly partial-onset seizures than placebo after 11 weeks of treatment, and side effects were generally resolved over time. Nearly all of the patients who finished the first part of the trial have elected to continue in a year-long extension study of the drug.

"Topiramate is a well-known, effective agent for the treatment of a variety of seizure disorders, but many patients experience challenging cognitive side effects while taking the immediate-release formulation of the drug," Barrow Neurological Institute of Phoenix professor of neurology and trial investigator Steve Chung said. "The PREVAIL trial showed that USL255, a once-daily, extended-release formulation of topiramate, is efficacious across a range of seizure types and patient severity."