(By Balaseshan) Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) stock jumped 38.35% in premarket, after the specialty pharmaceutical company received a tentative FDA approval of Trokendi XR to treat epilepsy.
Supernus received a tentative approval letter from the U.S. Food & Drug Administration (FDA) for Trokendi XR, a once-daily extended release formulation of topiramate (formerly known as SPN-538).
The letter states that the FDA completed its review of the Trokendi XR NDA and that no additional clinical trials are required.
The company's initial understanding is that final approval is conditioned on resolving a marketing exclusivity issue raised by the FDA regarding a specific pediatric population.
Supernus also learned that the FDA denied the Citizen's Petition filed in 2011 by Upsher Smith Laboratories as it relates to its NDA on Trokendi XR.
Chief Executive Jack Khattar said Supernus would continue to work closely with the FDA to further understand the outstanding issue and move forward towards final approval.
Epilepsy is a chronic neurological disorder, characterized by repeated seizures. It is estimated that about 3 million people in the U.S. and around 50 million people worldwide suffer from epilepsy.
SUPN closed Monday's regular session at $5.71. The stock has been trading between $4.30 and $7.01 for the past 52 weeks.