Supernus Pharmaceuticals, Inc. (SUPN) said Tuesday it received a tentative approval letter from the Food and Drug Administration for its epilepsy drug Trokendi XR. The news sent the company's shares up more than 73 percent in the morning trade.
Trokendi XR, formerly SPN-538, is a once-daily extended release formulation of topiramate.
The company's two epilepsy drug candidates under FDA review are SPN-538, an extended-release version of Johnson & Johnson's (JNJ) Topamax, and SPN-804, an extended-release version of Norvatis AG's (NVS) Trileptal.
Both Topamax and Trileptal are available in generic forms. The regulatory agency's decision on SPN-804 is anticipated in October this year.
According to Supernus, SPN-538 is designed to improve patient compliance and to have a better tolerability profile compared to the current immediate release products that are taken multiple times per day.
The FDA's letter stated that it has completed its review of the Trokendi XR NDA and that it required no additional clinical trials.
Supernus finds that the final approval is conditioned on resolving a marketing exclusivity issue raised by the FDA regarding a specific pediatric population.
Jack Khattar, chief executive officer, president and director of Supernus said, "We are pleased to announce that the FDA granted us tentative approval for Trokendi XR and that all of the scientific and procedural conditions for approval have been met. We will continue to work closely with the FDA to further understand the outstanding issue and move forward towards final approval."
About 3 million people in the U.S. and around 50 million people worldwide suffer from epilepsy.
Supernus Pharma went public on the NASDAQ stock exchange as recently as May 1, 2012, pricing its shares at $5 each.
SUPN is currently trading at $9.88, up $4.17 or 73.03 percent, on a volume of 424 thousand shares, against a three-month average volume of 67 thousand shares.
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