FDA approves Supernus' epilepsy drug Oxtellar XR

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Associated Press

Posted on October 22, 2012 at 1:01 PM

Updated Monday, Oct 22 at 1:01 PM

ROCKVILLE, Md. (AP) — Supernus Pharmaceuticals Inc. said Monday that the Food and Drug Administration approved its once-per-day epilepsy drug Oxtellar XR. Its shares jumped more than 10 percent in morning trading.

Oxtellar is a once-per-day drug approved to treat epilepsy in patients older than 6. Supernus said it is required to do additional research to evaluate the drug in younger patients. The primary ingredient in Oxtellar is oxcarbazepine, an epilepsy treatment that is usually taken twice a day. Supernus said it plans to launch the drug during the first quarter.

Supernus, which is based in Rockville, Md., received tentative FDA approval for another epilepsy drug, Trokendi XR, in June. Trokendi XR is a once-per-day version of an older drug called topiramate.

Shares of Supernus jumped $1.33, or 10.3 percent, to $14.30 in morning trading Monday. They have traded between $4.30 and $16.68 since the company went public on May 1.

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