FDA Grants Trokendi XR Tentative Label Expansion for Migraine Tx

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FDA Grants Trokendi XR Tentative Label Expansion for Migraine Tx
FDA Grants Trokendi XR Tentative Label Expansion for Migraine Tx

Supernus Pharmaceuticals has announced that the US FDA has granted tentative approval to the supplemental New Drug Application (sNDA) proposing a label expansion for Trokendi XR (topiramate) extended-release capsules to include prophylaxis of migraine headache in adults.

The tentative approval implies that the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval but it is subject to pediatric exclusivity expiring March 28, 2017. The FDA's final approval will not be in effect until the exclusivity period has expired.

Trokendi XR, an anticonvulsant, is already indicated as initial monotherapy and adjunct in partial-onset or primary generalized tonic-clonic seizures and as adjunct in Lennox-Gastaut Syndrome. It is presumed to exert its effects through 4 properties that may contribute to its efficacy for epilepsy. Topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.

Trokendi XR is available as 25 mg, 50 mg, 100 mg, and 200 mg strength tablets in 100-count bottles and as 30-count blister packages.

Reference

Supernus Receives FDA Tentative Approval for Expanded Label of Trokendi XR® to Include Migraine Prophylaxis in Adults. Supernus Pharmaceuticals Newsroom. http://ir.supernus.com/releasedetail.cfm?ReleaseID=985010. Published August 19, 2016. Accessed August 23, 2016

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