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FDA Approves Alzheimer’s Patch

July 10, 2007

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The U.S. Food and Drug Administration has approved the Exelon Patch, a once-a-day treatment said to slow the progression of Alzheimer’s disease.

Novartis, the company that makes the drug, already sells it in capsule form. The patch is seen as an improvement because the pills have side effects.

The drugmaker says the new therapy is the first and only transdermal treatment for Alzheimer’s in the US.

It says the Exelon Patch offers effective treatment based on placebo-controlled clinical trial results showing significant benefits to patients in terms of their memory and ability to perform everyday tasks as well as helping their overall functioning.

The patch maintains steady drug levels in the bloodstream, improving tolerability and allowing a higher proportion of patients to receive therapeutic doses of medication, potentially improving efficacy. It is applied to the back, chest or upper arm, and provides smooth and continuous delivery of medication through the skin over 24 hours.

Gastrointestinal side effects are commonly seen with this class of drugs called cholinesterase inhibitors.

Novartis says the target dose of Exelon Patch greatly reduces these side effects, with three times fewer reports of nausea and vomiting than with the capsule form of the drug.

“Exelon Patch represents a significant advance in the treatment of this debilitating disease," said George Grossberg, MD, at St. Louis University. "The unique delivery system helps both the patient and the caregiver by providing a much easier way to manage their therapy. The patch provides a visual reassurance for the caregiver that the patient is receiving their medication and helps the patient stay engaged in the activities of daily living.”

Exelon Patch is expected to be available in U.S. pharmacies soon. The medication was submitted for review in the European Union in late 2006.

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