Eslicarbazepine acetate: Phase III data

The identical, double-blind Phase III Study 093-045 and Study 093-046 in patients 18 years and older with epilepsy who were not well controlled by antiepileptic drugs showed that conversion to once-daily eslicarbazepine as monotherapy met the primary endpoint in both trials of reducing the proportion of patients achieving >=1 of 5 undisclosed predefined exit criteria signifying worsening seizure control at 16 weeks post-titration vs. historical controls. Eslicarbazepine was well tolerated. The trials enrolled patients with >=4 partial-onset seizures in the 8 weeks prior to screening and no 4-week seizure-free period while taking 1 or 2 antiepileptic drugs. Each trial included an 18-week double-blind treatment period consisting of a 2-week period for titration of eslicarbazepine, a 6-week period for taper or conversion off antiepileptic drugs and a 10-week monotherapy treatment period with once-daily 1,200 or 1,600 mg eslicarbazepine. The North American Study 093-045 enrolled 193 patients and the international Study 093-046 enrolled 172 patients.

In February, Dainippon Sumitomo's Sunovion Pharmaceuticals Inc. subsidiary said FDA accepted for review an NDA for Stedesa eslicarbazepine as a once-daily adjunctive therapy to treat partial-onset seizures in adults with epilepsy (see BioCentury, March 4). In April 2010, FDA issued a complete response letter for the product (see BioCentury, May 10, 2010). Sunovion said that pending the outcome of FDA's review of the NDA resubmission for Stedesa as adjunctive therapy, the company plans to submit an sNDA for the monotherapy indication. ...