FDA OKs 1st Alzheimer's Skin Patch
Once-Daily Exelon Patch Also Approved to Treat Mild to Moderate Parkinson's Disease Dementia
July 9, 2007 -- The FDA has approved Exelon Patch, the first skin patch for the treatment of mild to moderate Alzheimer's disease.
Exelon Patch is also approved to treat mild to moderate Parkinson's disease dementia, according to Exelon's maker, the drug company Novartis.
Exelon isn't a new drug. It's already available in capsules to treat mild to moderate Alzheimer's disease and mild to moderate dementia associated with Parkinson's disease.
In July 2006, researchers reported that putting Exelon in a patch form might simplify the drug's use (especially for people who have trouble swallowing pills) and reduce nausea and vomiting associated with Exelon's class of drugs.
Exelon Patch "greatly reduces" the drug's gastrointestinal side effects, says Novartis.
The patch is applied once daily to the back, chest, or upper arm. It maintains steady blood levels of the drug throughout the day, according to Novartis.
Exelon Patch's Approval
Novartis says that the FDA approved Exelon Patch based on results from an international study that included nearly 1,200 patients with mild to moderate Alzheimer's disease.
The patients took Exelon capsules, wore the Exelon patch, or got a placebo treatment.
"Exelon Patch showed similar efficacy to the highest doses of Exelon capsules and the recommended dose (9.5 milligrams per 24 hours) was generally well tolerated by patients," says Novartis.
At higher-than-recommended doses, the patch is associated with nausea, vomiting, diarrhea, appetite loss, and weight loss, notes Novartis.