A new extended-release formulation of topiramate (Qudexy XR, Upsher-Smith) is now available.
Qudexy XR was approved in March 2014 as initial monotherapy in patients >10 years old with partial-onset seizures or primary generalized tonic-clonic seizures. Also, it was approved as adjunctive therapy in patients >2 years old with partial-onset seizures, primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome.
Electrophysiological and biochemical evidence suggests that 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.
FDA approval was based on results from the Phase 3 PREVAIL trial (n=249) where Qudexy XR demonstrated efficacy and tolerability in epilepsy patients with refractory partial-onset seizures. A significantly greater median percent reduction from baseline in partial-onset seizure frequency was seen in the Qudexy XR treatment group vs. placebo (39.5% vs. 21.7%; P<0.001) after 11 weeks of treatment.
Qudexy XR is available as 25mg, 50mg, 100mg, 150mg, and 200mg extended-release capsules in 30-, 90-, and 500-count bottles. All Qudexy XR capsules may be swallowed whole or sprinkled on a spoonful of food.
For more information call (800) 654-2299 or visit QudexyXR.com.
This article originally appeared on MPR