FDA approves new dosage of Exelon (Novartis) for patients with Alzheimers

The FDA has approved a higher dose of Exelon (rivastigmine transdermal system), from Novartis, for the treatment of people with mild to moderate Alzheimer's disease. The new dosage strength provides physicians with a new treatment option for patients who are experiencing a decline in overall function and cognition. Approval of the patch was based on the 48-week OPTIMA study, a novel controlled trial in mild to moderate AD 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 compared to the 9.5 mg/24 h patch as measured by the instrumental activities of daily living scale (ADCS-IADL) at week 48. Improvement in cognition (measured by ADAS-Cog) compared to the lower dose was nominally statistically significant at 24 weeks but not at 48 weeks. This was one of the longest double-blind cholinesterase inhibitor trials to date. Several generic versions of Exelon capsules have been launched in USA.