An extended-release formulation of topiramate (Qudexy XR, Upsher-Smith Laboratories) has been shown to be sale and effective in refractory epilepsy patients in a global phase 3 clinical trial.
An extended-release formulation of topiramate (Qudexy XR, Upsher-Smith Laboratories) has been shown to be safe and effective in refractory epilepsy patients in a global phase 3 clinical trial.
The results were published in the June issue of Epilepsia.
The PREVAIL phase 3 clinical trial demonstrated that once-daily topiramate XR (also known as USL255) at 200 mg/day, significantly improved seizure control in adult subjects with refractory partial onset seizures (POS), and was safe and generally well tolerated, with few neurocognitive side effects.
In the trial, 249 adults with POS were randomized1:1 to once-daily topiramate XR (200 mg/day) or placebo after an 8-week baseline period. The primary and key secondary efficacy end points, measured during the 11-week blinded treatment phase, were median percent reduction in weekly POS frequency and responder rate (proportion of patient with ≥50% reduction in seizure frequency). Seizure freedom was also assessed. Safety (adverse events, clinical and laboratory findings), as well as treatment effects on quality of life and clinical global impression of change were also evaluated.
“The pharmacokinetic properties of this once-daily, extended-release formulation, along with the demonstrated efficacy and safety results from the [trial], support the role of extended release topiramate as a valuable treatment option for the management of epilepsy,” said William Pullman, MB BS, BMedSc, PhD, FRACP, chief scientific officer, Upsher-Smith.
“Once-daily dosing via sprinkle administration or intact capsule and tolerability of topiramate XR may support improved medication adherence,” Pullman said.