Trokendi XR Gets Final FDA Approval for Migraine Prophylaxis
Supernus announced that it has received final approval from the Food and Drug Administration (FDA) for Trokendi XR (topiramate) to expand its use as prophylaxis of migraine headache in patients aged ≥12 years.
In August 2016, the FDA granted tentative approval of the Company's one of two supplemental New Drug Applications (sNDAs). The final approval was contingent on the pediatric exclusivity of the drug in the adolescent population that expired March 28, 2017.
Trokendi XR is an extended-release formulation of topiramate, a sulfamate. Its efficacy for epilepsy and migraine prophylaxis is presumed by the following properties: 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 already indicated for initial monotherapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures; and adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome.
Trokendi XR is available in 25mg, 50mg, 100mg and 200mg extended-release capsules.
For more information call (866) 398-0833 or visit TrokendiXR.com.