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FDA expands indication of extended-release Qudexy XR for pediatric use
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The FDA has approved expanded indication of a topiramate extended-release capsule for the treatment of seizures in children aged two years and older, according to the drug’s manufacturer.
Topiramate (Qudexy XR, Upsher-Smith), is a capsule form antiepileptic used to treat partial onset seizures or primary generalized tonic-clonic seizures. This extended indication gives physicians the approval to prescribe the drug which can be sprinkled onto soft foods for children.
“The expanded indication gives physicians the option to prescribe Qudexy XR as initial monotherapy in patients as young as two years old,” William Pullman, MB BS, PhD, chief scientific officer at Upsher-Smith, in a press release. “This, combined with its ability to be sprinkled on soft food for ease of administration, makes it a viable treatment option for the pediatric patient population.”
The FDA previously approved topiramate as monotherapy for patients ten years or older suffering from partial onset seizures or primary generalized tonic-clonic seizures.
Topiramate is also approved for use in tandem with other drugs for pediatric use to treat partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome.
The drug has been approved by the FDA since March 2014, and has been available in the United States since June 2014.
The FDA based its approval on data from phase 3 trials of this topiramate capsule, which was published in the June 2014 issue of Epilepsia, to base its approval. Results from the clinical trial demonstrated that topiramate significantly improved seizure control in patients.