An oral once-daily extended release formulation of topiramate (Trokendi XR) for the treatment of epilepsy has received final approval from the US Food and Drug Administration (FDA), according to an announcement from Supernus Pharmaceuticals Inc.
The specialty pharmaceutical company said the product should be available in pharmacies over the next few weeks. It is indicated for initial monotherapy in patients 10 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 6 years of age and older with seizures associated with Lennox-Gastaut syndrome.
“We are very excited about the approval of Trokendi XR and its upcoming launch,” said Jack Khattar, chief executive officer, president and director of Supernus, in a press statement. “This is excellent news for Supernus, its shareholders, and patients with epilepsy. 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.”