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Positive Long-Term Results Reported for Qudexy XR (Extended-Release Topiramate) in Seizure Patients
A year-long, open-label extension study (PREVAIL OLE) has demonstrated that Qudexy XR (extended-release topiramate, Upsher-Smith Laboratories) is a generally well-tolerated adjunctive treatment option for a high proportion of patients with refractory partial-onset seizures (POS).
The PREVAIL OLE trial enrolled 97% of the participants who had completed the original randomized, double-blind, placebo-controlled, phase III PREVAIL study of Qudexy XR, a once-daily, broad-spectrum antiepileptic drug. Data from the new study were presented at the 68th annual meeting of the American Epilepsy Society, held December 5–9 in Seattle, Washington.
The completion rate in the PREVAIL OLE study was 70%. Most of the reported adverse were mild to moderate in severity. The median percent reduction in the frequency of weekly POS from the original PREVAIL trial baseline was 59% (all subjects combined) for the open-label treatment phase.
Qudexy XR is indicated as initial monotherapy in patients 10 years of age and older with POS or with primary generalized tonic-clonic seizures. It is also approved as an adjunctive therapy in patients 2 years of age or older with POS, with primary generalized tonic-clonic seizures, or with seizures associated with Lennox-Gastaut syndrome.
Qudexy XR and its authorized generic formulation, topiramate extended-release capsules (Upsher-Smith Laboratories), are the only extended-release topiramate products that are FDA-approved to be administered by carefully opening the capsule and sprinkling the entire contents onto a spoonful of soft food. All strengths of Qudexy XR and its authorized generic may be administered by this sprinkle method. According to their manufacturer, this makes them the only extended-release topiramate products approved for patients who have difficulty swallowing whole capsules or tablets.
In the PREVAIL OLE trial, the most common treatment-emergent adverse events (TEAEs) included headache (7.6%), weight decrease (7.6%), somnolence (7.1%), dizziness (6.2%), aphasia (5.2%), and fatigue (5.2%). The rates of individual neurocognitive or neuropsychiatric TEAEs newly reported during the study were mostly less than 3%, with the exception of aphasia (5.2%) and depression (3.8%).
The PREVAIL OLE study was an open-label extension of PREVAIL, which was a global phase III trial designed to evaluate the efficacy and safety of Qudexy XR as adjunctive therapy in 249 patients with refractory POS using a randomized, double-blind, placebo-controlled, parallel-group design. A total of 210 patients (97%) who completed PREVAIL enrolled in PREVAIL OLE. These participants underwent a 3-week, blinded-conversion phase, during which those previously assigned to receive placebo in PREVAIL were titrated to 200 mg/day of Qudexy XR, and those assigned to receive 200 mg/day of Qudexy XR were given matching placebo. The conversion phase was followed by a 52-week, open-label treatment phase. After completing 11 weeks of treatment, changes were allowed in the Qudexy XR dosage (in 50-mg/wk increments to a maximum of 400 mg/day) and to concomitant antiepileptic drugs.
More than 2 million people in the U.S. are estimated to have epilepsy, with about 150,000 new cases of the disorder diagnosed each year.
Source: Upsher-Smith Laboratories; December 8, 2014.