Upsher-Smith Laboratories announced it has received FDA approval for Qudexy XR (topiramate extended-release) capsules indicated as initial monotherapy in patients >10 years of age with partial-onset seizures or primary generalized tonic-clonic seizures. Qudexy XR is also approved as adjunct therapy in patients >2 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Qudexy XR allows patients to sprinkle capsule contents on soft food if they experience challenges swallowing whole capsules or tablets.
Qudexy XR is a sulfamate antiepileptic. Evidence suggests that topiramate blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of theGABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.
The FDA approval is 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 will be available as 25mg, 50mg, 100mg, 150mg, and 200mg extended-release capsules in 30-, 90-, and 500-count bottles. The product will be available in the second quarter of 2014.
For more information call (800) 654-2299 or visit QudexyXR.com.