Ortho-McNeil Neurologics Inc. announced a new breakthrough today as the FDA approved their new drug Razadyne ER for use. The new drug will help mild to moderate cases of the debilitating Alzheimer’s disease with a once daily option.
Approved by the U.S. Food and Drug Administration (FDA) in December 2004, RAZADYNE ER contains galantamine hydrobromide — first approved by the FDA in February 2001 as a twice-daily medication, REMINYL. In April 2005, the product name was changed to RAZADYNE. Approximately two million patients have been treated with REMINYL to date. In clinical trials, RAZADYNE ER provided comparable efficacy, safety, and tolerability to twice-daily galantamine with the convenience of once-daily dosing.
In a six-month clinical study, patients who started treatment with RAZADYNE ER — and stayed on it throughout the trial — had significantly better overall cognition (thinking and memory) and daily activities compared to patients taking placebo,” said Stephen Aronson, M.D., clinical assistant professor, University of Michigan Medical School.
This new capsule, like many once-daily medications releases its elements into the body over a 24-hour period, making it much simpler for patients to keep up.
“Alzheimer’s is an overwhelming diagnosis for the patient, for his or her spouse, for adult children and even for extended family members,” said Joanne Koenig Coste, renowned Alzheimer’s care pioneer and author of Learning to Speak Alzheimer’s. “Anything that may help make treatment more convenient for patients and their family members is always a welcome addition.”
In clinical trials, the most frequent adverse events with RAZADYNE ER were similar to those seen with RAZADYNE. The most common side effects are nausea, vomiting, diarrhea, loss of appetite, and weight loss. Typically, these side effects are mild and temporary. RAZADYNE may not be for everyone.
Some people experience a slowed heart rate, which may lead to fainting. Serious stomach problems can occur in people taking medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) or those at risk for stomach ulcers. Please see http://www.razadyne.com/ for full prescribing information or call 1-800-526-7736 for more information.
John Stith is a staff writer for Murdok covering technology and business.
