FDA Approves Qudexy XR for Migraine Indication
Qudexy XR is already approved for use as initial monotherapy to treat certain types of seizures.
The US Food and Drug Administration has approved the supplemental New Drug Applications (sNDAs) for Qudexy XR (topiramate) extended-release capsules for use as prophylaxis of migraine headache in adults and children aged ≥12 years.
Qudexy XR, a broad-spectrum antiepileptic, is already approved for use as initial monotherapy to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children aged ≥2 years; and as adjunctive therapy to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children aged ≥2 years.
The FDA granted tentative approval of the sNDAs in April 2016. A study to evaluate the efficacy and safety of Qudexy XR for use as prophylaxis of migraine in pediatric patients aged 6-11 years is planned.
Qudexy XR is available as 25mg, 50mg, 100mg, 150mg, and 200mg strength extended-release capsules.