Upsher-Smith presents favorable data from PREVAIL OLE study of Qudexy XR capsules

Apr 21 2015

Upsher-Smith Laboratories, Inc. (Upsher-Smith) presented data from a 52-week, open-label extension study (PREVAIL OLE) showing that Qudexy™ XR (topiramate) extended-release capsules offered a long-term adjunctive treatment option with a favorable tolerability profile for a high proportion of patients with refractory partial-onset seizures (POS). In a separate presentation, researchers also reported that when Qudexy™ XR capsules were opened and sprinkled onto soft food, they remained bioequivalent to intact capsules, making them a useful alternative for patients with swallowing difficulties. These results were presented at the American Academy of Neurology's (AAN) Annual Meeting in Washington, DC on April 18-25, 2015. Qudexy™ XR, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile, is an extended-release formulation of topiramate studied in a Phase 3, randomized, double-blind, placebo-controlled trial (PREVAIL) and the only extended-release topiramate formulation to have been approved by the Food and Drug Administration (FDA) for administration via the sprinkle method.

The PREVAIL OLE study of Qudexy™ XR enrolled 96.8% of participants who completed the original Phase 3 PREVAIL trial and had a completion rate of 70%. New individual neurocognitive / neuropsychiatric treatment-emergent adverse events (TEAEs) were reported in <3% of patients, with the exception of aphasia (5.2%) and depression (3.8%).

Data from a study evaluating an alternative administration method for Qudexy™ XR was also presented. In a Phase 1, randomized, single-dose crossover study (n=36) of Qudexy™ XR, researchers compared pharmacokinetic parameters when Qudexy™ XR was administered as an intact capsule to those when the capsule was opened and the beads were sprinkled onto soft food. AUC and C_max were bioequivalent between Qudexy™ XR beads sprinkled onto soft food and the intact capsule (90% CI: AUC_0-∞ 0.98-1.05; C_max 1.03-1.14). Median T_max was between 10-14 hours. In separate in vitro experiments, Qudexy™ XR beads were successfully passed through >/= 14 French G-/J-tubes.

"We are pleased that favorable data continues to emerge from the comprehensive clinical trials of Qudexy™ XR," said Steve Chung, M.D., Professor of Neurology at Banner University Medical Center, Phoenix and trial investigator. "The Phase 3 PREVAIL trial demonstrated that Qudexy™ XR met its primary and secondary endpoints for efficacy, and the open-label extension study supports the favorable safety profile and long-term use of Qudexy™ XR. This scientific data, combined with its dosing flexibility, substantiates the use of Qudexy™ XR as a potential treatment option for patients with seizure disorders."