Supernus Pharmaceuticals, Inc. (SUPN) recently received final U.S. Food & Drug Administration (:FDA) approval for Trokendi XR for the treatment of epilepsy.
Trokendi XR is a novel once-daily extended release formulation of Johnson & Johnson's (JNJ) Topamax (topiramate). This epilepsy product will be launched in a few weeks.
Along with granting approval, the FDA also agreed to a deferral of submission of post-marketing pediatric pharmacokinetic assessments, which were due in 2019, followed by clinical assessments in 2025. Supernus also got an FDA waiver for certain pediatric study requirements.
In Jun 2013, Supernus had received tentative approval for Trokendi XR. Trokendi XR had initially received tentative FDA approval in Jun 2012. However, at that time, the FDA had said that final approval depended on the resolution of a marketing exclusivity issue raised by the FDA regarding a specific pediatric population.
A request for final approval was filed in Dec 2012 along with a safety data update, a new package insert and packaging configurations for Trokendi XR. The FDA had informed Supernus that they will most likely grant this request in the form of a tentative approval because the review period would be expected to conclude within the second quarter, prior to the Jun 22, 2013 expiration of Topamax’ pediatric exclusivity.
Supernus has another epilepsy product, Oxtellar XR, in its portfolio. Oxtellar XR was launched in the U.S. in Feb 2013. Oxtellar XR was granted three years of marketing exclusivity by the FDA. The company reported meaningful growth in the Oxtellar XR prescriber base in the second quarter of 2013, totaling 3,648, up from 529 in the first quarter. Since its launch, more than 1,100 target physicians have prescribed Oxtellar XR.
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