Transdermal Patch for AD Treatment Approved in Higher Dosage
The U.S. Food and Drug Administration has approved a higher dose of Exelon® Patch (rivastigmine transdermal system) for the treatment of mild to moderate Alzheimer’s disease (AD). The new 13.3-mg/24 hours dosage strength of Exelon Patch provides physicians with a new treatment option for patients who are experiencing a decline in overall function and cognition.
Approval of the new dosage was based on the 48-week double-blind phase of the OPTIMA study, a novel controlled trial in mild to moderate AD patients who met the pre-defined criteria for functional and cognitive decline on the 9.5-mg/24 hours dose. Patients treated with the 13.3-mg/24 hours patch experienced statistically significant (p < 0.05) improvement in their overall function compared with the 9.5-mg/24 hours patch as measured by the Instrumental Activities of Daily Living Scale at Week 48 (a co-primary endpoint). Improvement in cognition (measured by ADAS-Cog) compared with the lower dose was nominally statistically significant at 24 weeks but not at 48 weeks (also a co-primary endpoint). This was one of the longest double-blind cholinesterase inhibitor trials to date.
During the 48-week dose-comparison phase of OPTIMA, no unexpected adverse events (AEs) leading to discontinuation were reported, and the safety profile of the higher dose was consistent with that of the currently approved doses of Exelon Patch. Overall, the percentage of patients with AEs leading to discontinuation was lower in the 13.3-mg/24 hours group compared with the 9.5-mg/24 hours group (9.6% versus 12.7%, respectively).
Exelon Patch is the first transdermal therapy approved for the treatment of mild to moderate AD. It is also approved to treat people with mild to moderate Parkinson’s disease dementia.
Source.“Higher Dose of Novartis Drug Exelon Patch Approved by FDA for Patients with Mild to Moderate Alzheimer’s Disease.” (2012, September 4). Retrieved September 20, 2012, from the PR Newswire website: http://s.tt/1mpAm.
New App Offers Mobile Biosensor Technology
SecuraTrac, a provider of mobile health and safety solutions focused on protecting older adults, children, and employees, has announced the development of a new technology based on its award-winning mobile app, SecuraFone®. Developed in conjunction with Vital Connect, a next-generation biosensor and secure cloud technology, SecuraFone Health can alert physicians, caregivers, and family in real time when an unexpected health event occurs.
SecuraFone Health will benefit consumers, patients, physicians, and caregivers by detecting falls, caregiver-defined heart rate changes, and respiration rate changes, as well as other key vital signs. When an unexpected change is detected, the app will send a real-time alert including information about the user’s location and other key details to designated contacts.
SecuraFone Health uses a sensor worn by the user on his or her chest or back to monitor vitals 24 hours per day. Patches are water resistant, can be worn in the shower, and are worn for 2 to 3 days before needing to be replaced. They have up to a 50-foot communication radius for sending notifications to the user’s smartphone. The monthly service is tied to a 24/7 emergency response center with trained health care staff.
For more information, visit http://www.securafone.com.
Source.“New Mobile Technology Alerts Doctors, Family of Health Events.” (2012, July 23). Retrieved September 20, 2012, from http://www.pr.com/press-release/428474.