FDA Grants Final Approval for Supernus Pharmaceuticals' Epilepsy Drug
Shares in Supernus Pharmaceuticals gained as much as 32 percent Monday on news the FDA issued final approval for its epilepsy drug Trokendi XR, a once-daily extended-release formulation of Johnson & Johnson's Topamax (topiramate). The company said Trokendi XR, which obtained tentative US approval last year while a marketing exclusivity issue regarding a specific paediatric population was being resolved, will be launched in the next few weeks.
In the final approval, the agency granted a waiver for certain paediatric study requirements and a deferral for submission of post-marketing paediatric pharmacokinetic assessments that are due in 2019, followed by clinical assessments in 2025, the company said. Trokendi XR is indicated as first-line monotherapy for patients at least 10 years old with partial onset or primary generalised tonic-clonic seizures. The drug is also approved as an adjunctive therapy for patients at least six years old with partial onset or primary generalised tonic-clonic seizures, as well as an adjunctive therapy for patients at least six years old with seizures associated with Lennox-Gastaut syndrome.
The drugmaker’s first epilepsy drug, Oxtellar XR (oxcarbazepine extended release), was approved by the FDA in October last year and launched in February.