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Razadyne ER (Galantamine Hydrobromide), Once-Daily Treatment, Now Available for Patients With Mild to Moderate Alzheimer's Disease

TITUSVILLE, NJ -- May 23, 2005 -- Razadyne(TM) ER (galantamine hydrobromide), a new once-daily treatment for the symptoms of mild to moderate Alzheimer's disease, is now available by prescription nationwide. The product is marketed by Ortho-McNeil Neurologics, Inc.

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(R). 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.

The Razadyne ER capsules contain a rate-controlling membrane that allows the medication to be released gradually over a 24-hour period. This new formulation contains an immediate and extended release dose that allows for the convenience of once-daily dosing.

"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 the clinical study, 965 patients were randomly assigned to receive Razadyne ER, twice-daily galantamine or placebo. Patients treated with Razadyne ER had significant improvement in cognition as measured by the mean change in Alzheimer's Disease Assessment Scale (ADAS-cog/11) scores compared to patients treated with placebo at six months.

The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) inventory was used as a secondary outcome measure in the clinical study. Patients treated with Razadyne ER had significantly better scores than the placebo group at six months.

Dosage began at 8 mg/day for four weeks and was increased to 16 mg/day for an additional four weeks, after which the dose could be increased to 24 mg/day based on safety and tolerability. Approximately 80 percent of patients completed the trial.

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.

Razadyne ER was developed under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group plc. It is approved for the treatment of mild to moderate Alzheimer's disease in 24 countries.


SOURCE: Ortho-McNeil Neurologics, Inc.

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