FDA Approves Supernus sNDA for Trokendi in Migraine Prevention

FDA has approved a Supernus Pharmaceuticals supplemental NDA for a label expansion for Trokendi XR (topiramate) to include migraine headache prevention in adults and adolescents 12 years and older. “Trokendi XR, with its novel formulation, provides full 24 hour coverage for patients with smooth pharmacokinetics compared to the immediate-release topiramate products, making it an important new treatment option for adult and adolescent patients suffering from migraine headache,” the company says. The product was previously approved as an initial monotherapy in patients six years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures; and adjunctive therapy in patients six years of age and older with seizures associated with Lennox-Gastaut syndrome.