Antiepileptic Granted Tentative Approval for Migraine Prophylaxis
Upsher-Smith announced that the Food and Drug Administration (FDA) has granted tentative approval for a supplemental New Drug Application (sNDA) for Qudexy XR (topiramate) extended-release capsules for use in adults as prophylaxis of migraine headache.
Topiramate is the most frequently prescribed drug by neurologists for the prevention of migraines but currently there are no extended-release formulations of topiramate approved formigraine prophylaxis in the United States. Evidence suggests that topiramate 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.
Qudexy XR, a broad-spectrum antiepileptic, is currently indicated for use as initial monotherapy in patients ≥2 years old with partial-onset or primary generalized tonic-clonic seizures, and adjunctive therapy in patients ≥2 years old with partial-onset or primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.
Qudexy XR is available as 25mg, 50mg, 100mg, 150mg, and 200mg strength capsules in 30-, 90-, and 500-count bottles.