FDA Approves Higher Dose of Exelon Patch
The Food and Drug Administration has approved a higher dose of the ExelonPatch (rivastigmine transdermal system) for the treatment of people with mild to moderate Alzheimer’s disease, according to a release from Novartis, which manufactures the patch. The release quotes Jeffrey Cummings MD, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health, as saying, “Having multiple options for the treatment of mild to moderate Alzheimer’s disease will help physicians better care for patients with the hope of improving function and cognition.”
Approval of Exelon Patch 13.3 mg/24 h was based on the 48-week double-blind phase of the OPTIMA study, a novel controlled trial in mild to moderate Alzheimer's patients who met the pre-defined criteria for functional and cognitive decline on the 9.5mg/24 h dose. Patients treated with the 13.3 mg/24 h patch experienced statistically significant improvement in their overall function.
During the 48-week dose-comparison phase of OPTIMA, no unexpected adverse events leading to discontinuation were reported and the safety profile of the higher dose was consistent with that of the currently approved doses of Exelon Patch.