Tentative FDA approval for Supernus' Trokendi XR

USA-based specialty drug firm Supernus Pharmaceuticals (Nasdaq: SUPN) says it has received a tentative approval letter from the Food and Drug Administration for Trokendi XR, a once-daily extended release formulation of topiramate, the active ingredient of Johnson & Johnson's widely used epilepsy drug Topamax, which is now off patent.

Supernus’ stock, which has lost 12% of its value since the company went public in May, was up 137% at $13.56 on the news, noted Reuters.

The letter states that the FDA completed its review of the Trokendi XR New Drug Application and that no additional clinical trials are required. The company says its initial understanding is that final approval is conditioned on resolving a marketing exclusivity issue raised by the FDA regarding a specific pediatric population.