The FDA has expanded the indication for transdermal rivastigmine to include patients with severe Alzheimer’s disease.
The approval means that the transdermal agent is indicated for use in any Alzheimer’s patient, irrespective of disease stage or severity. The expanded indication is the first of its type for any Alzheimer’s drug, according to a statement from drug manufacturer Novartis.
Supporting evidence for the expanded approval came from a randomized trial comparing the highest approved dosage of transdermal rivastigmine (13 mg/24 hr) and the lowest approved dosage (4.6 mg/24 hr). The trial involved 716 patients with severe Alzheimer’s disease, associated with a Mini-Mental State Examination score of 3 to 12.
The 24-week assessment showed significantly less deterioration in activities of daily living scale and the severe impairment test battery in patients who received the high-dose patch (P=0.0247, P<0.0001). Additionally, the high-dose group had significantly greater improvement in the clinical global impression of change assessment (P=0.0023).
The two groups did not differ with respect to scores on the neuropsychiatric inventory.
Adverse events and severe adverse events occurred in a similar proportion of patients in the two treatment arms (74.6% high-dose versus 73.3% low-dose for adverse events, and 14.9% versus 13.6% for severe adverse events).
Discontinuation because of adverse events and serious adverse events occurred more frequently in the high-dose group (13.5% versus 10.9% and 8.2% versus 4.5%, respectively).
Results of the randomized trial were reported earlier this year at the American Academy of Neurology and the American Association for Geriatric Psychiatry meetings.
By Charles Bankhead, Staff Writer, MedPage Today