FDA Grants Tentative Approval for Trokendi XR in Migraine Prophylaxis
Supernus announced that the Food and Drug Administration (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 four 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 25mg, 50mg, 100mg, and 200mg strength tablets in 100-count bottles and as 30-count blister packages.
For more information call (866) 398-0833 or visit TrokendiXR.com.