Supernus Pharmaceuticals Inc. (SUPN) said the U.S. Food and Drug Administration gave final approval for its Oxtellar once-daily extended-release epilepsy treatment.
Shares were up 18% at $15.25 in premarket trading. Through Friday's close, the stock has more than tripled from its initial public offering price of $5.
The specialty-drug maker, which went public in May, said it is gearing up to launch Oxtellar XR in the first quarter of next year, as expected.
Supernus focuses on developing and commercializing products for diseases of the central nervous system. Its other products in development include treatments for attention deficit hyperactivity disorder, or ADHD.
Oxtellar--an extended-release formulation of oxcarbazepine--is indicated as an adjunctive therapy in the treatment of partial seizures in adults and in children six to 17 years of age.
The FDA granted a waiver for the pediatric-study requirement for ages birth to one month and a deferral for submission of post-marketing assessments for children ages one month to six years.
The company also received tentative approval for its Trokendi XR epilepsy treatment. It has delayed plans to launch Trokendi XR to the third quarter of 2013 from the end of this year on expectations that final FDA approval may not be made effective until a marketing-exclusivity period expires.
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