The Phase III clinical trial is evaluating the patients under 18 to 75 years of age with refractory partial-onset seizures with or without secondary generalised seizures.
Topiramate is an internally developed program for the management of epilepsy in adults, using the company’s proprietary formulation technology.
Topiramate is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.
Upsher-Smith said that depending on results of preclinical models of seizures, it is expected to focus on development of Tonabersat for the treatment of epilepsy.
Alan Rauch, chief medical officer and vice president medical and regulatory affairs of Upsher-Smith, said: “The initiation of the Phase III trial for USL255 is a key milestone in Upsher-Smith’s vision of becoming a leader in the CNS field. There is a significant unmet need in the treatment of epilepsy, with as many as 30% of patients not adequately controlled using current antiepileptic drugs.
“Poor medication compliance may be a contributing factor, and we are excited about the potential for USL255 to offer patients and clinicians a new treatment option with the potential for improved compliance.”