FDA approves Oxtellar XR as monotherapy to treat partial-onset seizures in adults and in children 6 to 17 years of age . Supernus Pharma

Supernus Pharmaceuticals, Inc. announced that the FDA has approved the Company�s supplemental new drug application (sNDA) for Oxtellar XR .The application requested FDA approval to expand the indication for Oxtellar XR beyond the current indication of adjunctive therapy in the treatment of partial-onset seizures in adults and in children 6 to 17 years of age and to include monotherapy. About Oxtellar XR- Oxtellar XR is the first approved novel, oral once-daily extended release formulation of oxcarbazepine for the treatment of partial-onset seizures in patients 6 years of age and older. The product is available in 150mg, 300mg, and 600mg extended-release tablets.

According to Supernus, the monotherapy market could be around five-fold the size of the adjunctive therapy market, markedly increasing the potential sales for Oxtellar XR. Supernus plans to launch it as monotherapy in the first quarter of 2019 and take the drug into Phase III trials for bipolar disorder in the second half of that year.