FDA Expands Trokendi XR Use in Children

The sNDA includes a modification of the indication for patients aged 6–10 years.
The sNDA includes a modification of the indication for patients aged 6–10 years.

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Trokendi XR (topiramate;Supernus) extended-release capsules.

The sNDA includes a modification of the indication by adding monotherapy treatment for partial onset or primary generalized tonic-clonic seizures in patients aged 6–10 years. Trokendi XR was previously indicated as initial monotherapy in patients aged ≥10 years and older with partial onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients aged ≥6 years with partial onset or primary generalized tonic-clonic seizures.

Trokendi XR is also indicated as adjunctive therapy in patients aged ≥6 years with seizures associated with Lennox-Gastaut syndrome

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Trokendi XR is an anticonvulsant that exerts 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.

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