FDA Approves Rivastigmine Patch for Alzheimer's Disease

EAST HANOVER, N.J., July 10 -- The FDA has approved a rivastigmine transdermal patch for mild to moderate Alzheimer's disease, Novartis announced here.

The patch (Exelon Patch) is the first approved transdermal system for treatment of Alzheimer's disease. The patch has also won approval for mild to moderate Parkinson's disease dementia. Rivastigmine oral formulations were already approved for the Alzheimer's indication.

The new approval of rivastigmine patch came on the basis of results from the international IDEAL (Investigation of transDermal Exelon in ALzheimer's disease) trial, involving nearly 1,200 patients.

In that trial, the patch demonstrated similar efficacy to the highest doses of rivastigmine capsules and the target dose (9.5 mg/24 hours) was well tolerated by patients. (See ICAD: Patch Smoothes Alzheimer's Drug Delivery)

Novartis said the most common side effects in the IDEAL trial were gastrointestinal symptoms, such as nausea and vomiting, that are typical of all cholinesterase inhibitors. But those toxicities were three times more common among patients treated with oral rivastigmine than compared with patients who were treated with the patch.