FDA approves first Alzheimer’s patch
pharmafile | July 13, 2007 | News story | Sales and Marketing |Â Â Â
The FDA has approved Novartis' Exelon Patch, the first ever skin patch treatment for Alzheimer's disease.
Novartis said the once-daily treatment was popular with careers, who could easily see whether patients are taking their medicine, and would improve compliance.
Global head of development at Novartis Pharma James Shannon said: "Innovation isn't just about developing new compounds, but also about meeting therapeutic needs by taking existing knowledge and applying it in new ways.
"Exelon Patch addresses an important medical need by delivering a proven drug in an entirely new form that meets the needs of patients and their caregivers."
Designed with patient compliance in mind the patch can be applied to the back, chest or upper arm. Novartis said it provides smooth and continuous delivery of Exelon for 24 hours and minimises the gastrointestinal side effects common to oral cholinesterase inhibitors such as Exelon.
"Exelon Patch represents a significant advance in the treatment of this debilitating disease," said George Grossberg, MD, at St. Louis University in St. Louis, Missouri.
"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 approved for mild to moderate Alzheimer's disease and has shown significant improvement in memory and ability to perform everyday activities compared to placebo. It also gained a US licence for mild to moderate Parkinson's disease dementia.
Europe regulators are currently considering the treatment, which was submitted for their approval at the end of 2006.
