The US Food and Drug Administration (FDA) has approved another once-daily extended-release formulation of topiramate (Qudexy XR, Upsher-Smith Laboratories Inc), the company announced.
It is indicated as initial monotherapy in patients 10 years of age or older with partial-onset seizures or primary tonic-clonic seizures, and also approved as adjunctive therapy in patients 2 years of age or older with partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome.
The new formulation is available in 25-, 50-, 100-, 150-, and 200-mg extended-release capsules, the statement notes. Capsules can be opened and the contents sprinkled on a spoonful of soft food to facilitate dosing. "This makes it the only approved extended-release topiramate product for patients who experience challenges swallowing whole capsules or tablets," the release adds.
Another oral once-daily extended-release topiramate product (Trokendi XR, Supernus Pharmaceuticals Inc) was approved in August 2013. It is indicated for initial monotherapy in patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures, adjunctive therapy in patients 6 years of age and older with partial-onset or primary generalized tonic-clonic seizures, and adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome.
Approval for Qudexy XR is based on data from the phase 3 PREVAIL study, presented in December 2013 at the American Epilepsy Society 67th Annual Meeting, and reported by Medscape Medical News at that time.
PREVAIL included 249 patients with partial-onset seizures with 8 or more seizures and 21 or fewer seizure-free days during an 8-week baseline phase. Patients who were taking 1 to 3 other antiepileptic drugs (AEDs) were randomly assigned to also receive the active drug or placebo.
Results showed that at 11 weeks (3-week titration plus 8-week maintenance), the active treatment was associated with a significantly greater median percentage reduction in seizure frequency compared with placebo (39.5% vs 21.7%; P < .001.) The 50% responder rate was also significantly greater (37.9% vs 23.2%; P = .013).
Subgroup analysis revealed that the drug was effective in patients with all types of partial-onset seizures with a variety of concomitant AEDs and in the most refractory of patients.
"PREVAIL demonstrated that Qudexy XR was efficacious and generally well-tolerated, particularly with respect to the incidence of cognitive side effects," said Steve Chung, MD, professor of neurology at the Barrow Neurological Institute in Phoenix and trial investigator, in the statement. "As a physician, I'm encouraged that Qudexy XR will be an available treatment option for many patients."
Qudexy XR will be available to patients in the second quarter of 2014, the company notes. More information is available at www.qudexyxr.com.
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Cite this: FDA Okays Another Extended-Release Topiramate for Epilepsy - Medscape - Mar 13, 2014.