Long-term efficacy and safety of adjunctive extended-release oxcarbazepine (Oxtellar XR^® ) in adults with partial-onset seizures.

ABSTRACT:

Objective

To evaluate long-term outcomes of adjunctive therapy with SPN-804 (Oxtellar XR^® , Supernus Pharmaceuticals), an extended-release tablet formulation of oxcarbazepine (OXC), in adults with refractory partial-onset seizures.

Methods

After completing a 16-week double-blind, placebo-controlled trial of SPN-804 at fixed dosages (1200 or 2400 mg QD), patients entering this open-label extension study were converted in blinded fashion to 1200 mg QD SPN-804 as a target starting dose for long-term treatment. Patients were followed for 1 year, during which SPN-804 dosages could be adjusted up to 2400 mg/day according to clinical response.

Results

Of 214 patients, 84% completed 1-year open-label treatment. Median maintenance SPN-804 dosage was 1200 mg; <10% of

SUBMITTER: Chung SS 

PROVIDER: S-EPMC5042072 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature