Phase III data for Qudexy XR for Epilepsy- Upsher-Smith Labs

Upsher-Smith Laboratories presented findings from a year-long, open-label extension (OLE) study (PREVAIL OLE) of Qudexy XR (topiramate extended-release) capsules that demonstrated the drug as a generally well-tolerated adjunctive treatment option for a high proportion of patients with refractory partial-onset Epileptic seizures (POS). The PREVAIL OLE study enrolled 96.8% of participants who completed the original randomized, double-blind, placebo-controlled, Phase III PREVAIL trial of Qudexy XR. The PREVAIL OLE study completion rate was 70%.

The majority of adverse events reported were mild to moderate in severity. The median percent reduction in weekly POS frequency from the original PREVAIL trial baseline was 59% (all subjects combined) for the open-label treatment phase. The most common Treatment Emergent Adverse Events (TEAEs) (> or = 5% of all patients) were headache (7.6%), weight decrease (7.6%), somnolence (7.1%), dizziness (6.2%), aphasia (5.2%), and fatigue (5.2%). The incidence of individual neurocognitive or neuropsychiatric TEAEs newly reported during the OLE was mostly less than 3%, with the exception of aphasia (5.2%) and depression (3.8%). Data from the study were presented for the first time at the 68th Annual Meeting of the American Epilepsy Society.