ROCKVILLE, Md. (AP) -- Shares of Supernus Pharmaceuticals Inc. more than doubled in price Tuesday after the specialty drugmaker said regulators have moved closer to granting final approval to its potential epilepsy treatment Trokendi XR.
The Rockville, Md., company said the Food and Drug Administration gave tentative approval for the once-daily treatment and told Supernus it would require no additional clinical trials.
Final approval, which will allow Supernus to sell the drug as an epilepsy treatment, depends on whether it can resolve "a marking exclusivity issue" tied to a specific pediatric population, the company said.
CEO Jack Khattar said the company must meet with regulators to learn more about the issue. He could offer no time frame for when final approval may come.
Trokendi XR is an extended-release version of the epilepsy treatment known generically as topiramate. Trokendi is designed to be taken once a day, while the older medication must be taken several times daily.
Supernus has no products on the market but is developing treatments for epilepsy and attention deficit hyperactivity disorder.
The company, which went public last month, saw its stock price soar $7.07 to $12.78 per share in afternoon trading Tuesday, more than double the $5.71 closing price Monday.
