Specialty pharmaceutical company Supernus Pharmaceuticals is set to launch once-daily extended release formulation of topiramate, Trokendi XR, to treat epilepsy following the final FDA approval.
Approved for use as recommended in the agreed-upon labeling, Trokendi XR will be made available in 25mg, 50mg, 100mg and 200mg extended-release capsules.
The antiepileptic drug (AED) is indicated for initial monotherapy in patients aged 10 years and more with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients aged six years and more with partial onset or primary generalized tonic-clonic seizures.
Additionally, it is indicated as adjunctive therapy in patients aged six years and more with seizures associated with Lennox-Gastaut syndrome.
Supernus chief executive officer, president and director Jack Khattar said, “We remain committed to the epilepsy community and very much look forward to now having two products, Trokendi XR and Oxtellar XR, available to patients.”
A waiver for certain pediatric study requirements was granted by FDA in addition to a deferral for submission of post-marketing pediatric pharmacokinetic assessments due in 2019 followed by clinical assessments in 2025.