Exelon: Improved Treatment for Alzheimer’s by a Transdermal Patch

In the United States, approximately 4.5 million Americans have the debilitating Alzheimer’s disease (Worldwide affecting approximately 15 million people) and expected to reach 14 million by 2050, as the population gets older. The disease is progressive brain disorder, causes brain cells to be destroyed or die over a period time: Memory loss, inability to reason, learn, make judgments, communicate and perform daily activities. Also, symptoms include change in personality, behavior, agitation, delusions or hallucinations. Eventually, the person will need constant supervision and care, including help with eating and toileting. The loss of brain function itself will eventually cause death.

Currently, drugs are available to treat the symptoms of Alzheimer’s, but there is no cure. Novartis Pharmaceuticals Corporation received Food and Drug Administration approval (April 2000) for the sale of Exelon to treat mild to moderate Alzheimer’s disease. (Also, treats Parkinson’s disease dementia) The drug inhibits the breakdown of a brain chemical called acetylcholine (cholinesterase inhibitors), which is vital link for nerve cells to communicate with each other or call upon the brain to recall memories. Other cholinesterace medications include Aricept (donepezil) and Reminyl (galantamine). Exelon administered by capsules and oral solution. Sometimes Alzheimer’s patients have a difficult time swallowing the pills. Exelon can cause side effects: Nausea, vomiting, loss of appetite, weight loss, weakness or lack of energy, dizziness, diarrhea, headaches, and stomach pain.

Norvatis Pharmaceuticals Corporation has been developing an improved alternative method for administering Exelon. Announced in July 2006 at the International Conference of Alzheimer’s Disease and Related Disorders, sponsored by the Alzheimer’s Association, an alternative dose Exelon skin patch or transdermal patch. This method eliminates taking the medication twice daily. Exelon capsules and ensures the medication is properly taken, especially when caregivers have the responsibility for administering the medication. The advantage provides controlled and continues delivery of the drug at higher dosage compared to the pill, directly into the bloodstream, and reduced by three times (seven percent vs. 23 percent) the side effects experienced including nausea and vomiting (Bypassing the gastrointestinal tract reduces fewer side effects). Also, the patch demonstrates a very good adhesion over 24 hours inclusive of everyday situation such as bathing and in hot weather. During six month trial of 1,195 patients with Alzheimer’s, compared taking 12 milligrams of Exelon a day by mouth and taking a high dose patch, equivalent to 17.4 milligrams. Trial users of the patch scored slightly better cognitive test results than the lower dosage of pill users. Also, less than eight percent of patients experienced moderate or severe abnormal redness of the skin. Norvatis plans on seeking FDA approval for Exelon patch by the end of 2006.

According to Dr. Sam Gandy, director of the Farber Institute for Neurosciences at Philadelphia’s Thomas Jefferson University, and an Alzheimer’s Association spokesman, said: ‘The patch clearly improves patient’s quality of life”.