Article Date: 09 Jul 2007
The Swiss drug company Novartis announced today that its new product Exelon Patch has been approved by the US Food and Drug Administration (FDA) as the first skin patch for patients with mild to moderate Alzheimer's disease.
The FDA also approved the product for the treatment of patients with mild to moderate Parkinson's disease dementia, a distinct and common disorder that affects 20 per cent of people diagnosed with Parkinson's.
Exelon Patch maintains steady bloodstream levels of the the drug rivastigmine (a cholinesterase inhibitor) for 24 hours via a transdermal patch that is applied to the back, chest or upper arm of the patient.
This method extends the drug's tolerability and its effectiveness over a wider range of patients, some of whom may not be able to take the oral capsule version because of the increased prevalence of gastrointestinal side effects often seen with cholinesterase inhibitors.
Novartis said that innovation wasn't just about developing new drugs but also about finding ways to deliver existing drugs in new ways to meet the needs of patients and caregivers.
The new therapy was tested in placebo-controlled clinical trials and improved Alzheimer patients' memory, ability to do everyday things and overall functioning. Also, compared with the oral capsule, the patch version resulted in three times fewer reported incidents of nausea and vomiting.
The trial was called the international IDEAL (Investigation of Transdermal Exelon in ALzheimer's disease) clinical trial and involved nearly 1,200 patients with mild to moderate Alzheimer's disease. The efficacy of the patch version of Exelon was similar the highest doses of the capsule version, being well tolerated by patients in the target dose of 9.5 mg per 24 hours.
Novartis said the product should be available in US pharmacies soon. It was submitted for approval in the European Union late last year.
According to the clinical trial results, the patch was preferred by over 70 per cent of caregivers because it interfered less with their daily life, was easier to use and helped them follow the treatment schedule.
Approximately 18 million people worldwide have Alzheimer's, with more than 5 million of them in the US. This number is expected to reach 7.7 million by 2030.
Alzheimer's is a progressive degenerative disease of the brain that impairs memory, thinking and behaviour, robbing people of their ability to carry on with their everyday lives. It affects mostly people over 65 years old.
Parkinson's is also a chronic, progressive neurological disorder that affects about 1.5 million people in the US, 20 per cent of whom have Parkinson's dementia, a distinct disorder that reduces memory, decision making, and attention.
by: Catharine Paddock
Writer: Medical News Today