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.