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Supernus med gets label expansion for migraine

April 6, 2017

Supernus Pharmaceuticals Inc. (SUPN) said its epilepsy drug, Trokendi XR (topiramate), secured label expansion approval from the Food And Drug Administration (FDA) as a migraine prevention treatment in adults and adolescents 12 years and older.

Label expansions are attempts by drug manufacturers to demonstrate that the drug works for additional kinds of patients or diseases beyond the original use for which the drug was approved.

Trokendi XR was first approved in August 2013 for the treatment of epilepsy.

The Rockville, Madison-based Supernus had submitted a label expansion request to the agency by filing Supplemental New Drug Applications (sNDAs) to expand the drug’s usage. The company specializing in the treatment of central nervous system diseases, was granted tentative approval of one of the two sNDAs in August last year, with final approval subject to the pediatric exclusivity of the innovator’s drug in the adolescent population, which expired March 28, 2017.

“Trokendi XR, with its novel formulation, provides full 24 hour coverage for patients with smooth pharmacokinetics compared to the immediate-release topiramate products, making it an important new treatment option for adult and adolescent patients suffering from migraine headache,” said Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. (See also, Amgen Reports Positive Migraine Phase 3 Data.)

The positive news lifted Supernus’ stock 5% during pre-market hours on Thursday. However, the stock lost those gains by 12 p.m. ET, when it was trading at $30.00 per share.

Last month, the company’s stock price plunged after it settled a patent infringement dispute that allows Teva Pharmaceuticals Industries Ltd.’s (TEVA) group company Actavis to start selling its Trokendi XR generic on January 1, 2023 or earlier under certain conditions. It followed a similar settlement that allows Zydus Pharmaceuticals (USA) Inc. and its parent company Cadila Healthcare Ltd. to begin selling a generic version of Trokendi XR by 2023.


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