A transdermal patch delivering rivastigmine (Exelon) at a 40% higher rate than the previous maximum strength has been cleared by the FDA for patients with mild to moderate Alzheimer’s disease, its manufacturer said.
The newly approved patch provides 13.3 mg of the drug over 24 hours, according to Novartis. Formulations delivering 9.5 and 4.6 mg per 24 hours were previously approved.
Approval was based on a 48-week, double-blind trial comparing the 13.3 and 9.5 mg/24-hour formulations, the company said. Patients receiving the high-dose patch showed significant improvements in their ability to perform ordinary activities of daily living on a standard scale, one of two primary endpoints in the study.
On the other endpoint, ratings of cognitive function, the high-dose patch led to significant improvements at 24 weeks but not at the trial’s end.
Rates and types of adverse events were similar with the two dosages. Discontinuations because of adverse events were somewhat less frequent with the higher-dose patch (9.6% versus 12.7%).
Rivastigmine is an acetylcholinesterase inhibitor that boosts activity in surviving cholinergic neurons, helping to compensate for the neurodegeneration caused by Alzheimer’s disease. It does not modify the underlying disease process.
By John Gever, Senior Editor, MedPage Today
Published: September 05, 2012
© 2012 MedPage Today, LLC.