The FDA has approved a 13.3mg/24h dosage strength of Exelon Patch (rivastigmine transdermal system; Novartis) for the treatment of patients with mild to moderate Alzheimer’s disease (AD).

Approval of Exelon Patch 13.3mg/24h was based on the 48-week double-blind phase of the 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/24h dose. Patients treated with the 13.3mg/24h patch experienced statistically significant (P<0.05) improvement in their overall function compared to the 9.5mg/24h patch as measured by the instrumental activities of daily living scale (ADCS-IADL) at Week 48 (a co-primary endpoint). Improvement in cognition (measured by ADAS-Cog) compared to the lower dose was nominally statistically significant at 24 weeks but not at 48 weeks (also a co-primary endpoint).

Exelon Patch (rivastigmine transdermal system) 4.6mg/24 hours, 9.5mg/24 hours, and 13.3mg/24 hours is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type and mild to moderate dementia associated with Parkinson’s disease.

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