The Medical Letter on Drugs and Therapeutics
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1428
Topiramate Extended-Release (Trokendi XR) for Epilepsy
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The FDA has approved a once-daily extended-release (ER) formulation of the antiepileptic topiramate (Trokendi XR – Supernus) for initial monotherapy in patients ≥10 years old with partial onset seizures or primary generalized tonic-clonic seizures and for adjunctive therapy in patients ≥6 years old with partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Topiramate has been available for many years as an immediate-release (IR) formulation (Topamax, and generics) for the same indications in patients ≥2 years old.1

CLINICAL STUDIES — No new safety or efficacy data were required for the new formulation. Approval was based on the results of clinical studies with IR topiramate and unpublished bioequivalence studies, summarized in the package insert, comparing the pharmacokinetics of the ... more      

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Title: Topiramate Extended-Release (Trokendi XR) for Epilepsy
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