Extended-Release Topiramate Wins Tentative Approval for Migraine Prophylaxis in Adults

Product is currently indicated for tonic-clonic seizures

The FDA has expanded the labeling for topiramate extended-release capsules (Qudexy XR, Upsher-Smith Laboratories) to include prophylaxis of migraine headache in adults. It is the first extended-release topiramate formulation approved for migraine prophylaxis in the United States.

Qudexy XR has been available in the U.S. since June 2014. It is currently indicated for use as initial monotherapy in patients 2 years of age and older with partial-onset or primary generalized tonic-clonic seizures and for adjunctive therapy in patients 2 years of age or older with partial-onset or primary generalized tonic-clonic seizures, or seizures associated with Lennox–Gastaut syndrome.

Topiramate is a sulfamate-substituted monosaccharide. Qudexy XR is available as 25-mg, 50-mg, 100-mg, 150-mg, and 200-mg capsules for oral administration; the capsules may be swallowed whole or opened and sprinkled onto a spoonful of soft food.

A syndrome consisting of acute myopia associated with secondary angle-closure glaucoma has been reported in patients receiving topiramate. Symptoms include the acute onset of decreased visual acuity and/or ocular pain. Topiramate treatment has also been associated with oligohydrosis (resulting in hospitalization in some cases) and metabolic acidosis.

Sources: Upsher-Smith Laboratories; June 9, 2016; and Qudexy XR prescribing information; March 2015.