Exelon Patch(rivastigmine transdermal system)

Exelon Patch (rivastigmine transdermal system) was approved on August 31, 2012, for the treatment of mild to moderate dementia of the Alzheimer’s type and mild to moderate dementia associated with Parkinson’s disease. A Supplemental New Drug Application (sNDA) was received on October 31, 2011, leading to the approval of a new dosage strength of 13.3 mg/24 hours. The initial treatment dose is 4.6 mg/24 hours, with effective dosages being 9.5 mg/24 hours or 13.3 mg/24 hours. The minimum duration at a previous dose before increasing is 4 weeks.

Efficacy findings for the 15 cm patch showed an ADAS-cog mean change from baseline of -0.2, 1.0, and 4.1, with corresponding p-values of 0.09, 0.03, and 0.23. For the 10 cm patch, ADAS-cog mean change from baseline was 0.6, 2.2, and 4.9. ADCS-IADL mean change from baseline for the 15 cm patch was -0.2, 0.1, and -0.7, with p-values of 0.11 and 0.25 for the first two. For the 10 cm patch, ADCS-IADL mean change from baseline was -0.8 and -0.4.

Safety data indicated that the most commonly observed adverse reactions (>5% and higher than with placebo) were nausea, vomiting, and diarrhea. The discontinuation rate due to adverse events for Exelon Patch 9.5 mg/24 hours was 9.6%, compared to 5.0% for placebo. Discontinuation due to nausea for Exelon Patch 9.5 mg/24 hours was 0.7%. Insomnia was reported in 4% of the 10 cm group. Abdominal pain incidence in the placebo group was 1%. A total of 1388 patients were treated for at least 12 weeks, 1182 for at least 24 weeks, and 582 for at least 48 weeks.