FDA gives Upsher-Smith tentative approval for new Qudexy XR indication

SILVER SPRING, Md. — The Food and Drug Administration has granted tentative approval to Upsher-Smith Laboratories’ application for a new indication for its Qudexy XR (topiramate) extended-release capsules as a preventative therapy for migraine headaches. 

 

The drug is currently approved for use as both a primary therapy for partial onset or primary generalized tonic-clonic seizures in patients older than 2 years of age and as an adjunctive therapy for partial onset and primary generalized tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome. 

 

“Topiramate is the molecule prescribed most frequently by neurologists for the prevention of migraines. However, there are currently no extended-release topiramate formulations approved for migraine prophylaxis in the US,” Upsher-Smith chief scientific officer and biotech research institute division preside William Pullman said. “We look forward to bringing this treatment option to the migraine community, and will continue to work with the FDA to gain final approval.”