FDA Approves Epilepsy Drug Trokendi XR (Topiramate)
Treatment to be launched soon (August 19)
The FDA has issued final approval for Trokendi XR (Supernus Pharmaceuticals, Inc.), a once-daily extended-release formulation of topiramate, for the treatment of epilepsy. The product is expected to be launched over the next few weeks.
The agency’s approval letter states that it has completed its review of the application and that Trokendi XR is approved effective August 16, 2013 for initial monotherapy in patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures; for adjunctive therapy in patients 6 years of age and older with partial-onset or primary generalized tonic-clonic seizures, and for adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome.
The FDA granted a waiver for certain pediatric study requirements and a deferral for submission of post-marketing pediatric pharmacokinetic assessments, which are due in 2019, followed by clinical assessments in 2025.
Trokendi XR will be available in 25-mg, 50-mg, 100-mg, and 200-mg extended-release capsules.
Source: Supernus Pharmaceuticals; August 19, 2013.