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news.New Jersey-headquartered Ortho-McNeil Neurologics has launched Razadyne ER, a new once-daily treatment for the symptoms of mild to moderate Alzheimer's disease, in the US.
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Approved by the FDA in December 2004, Razadyne ER contains galantamine hydrobromide – first approved by the FDA in February 2001 as the 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 and, in clinical trials, Razadyne ER provided comparable efficacy, safety, and tolerability to twice-daily galantamine with the convenience of once-daily dosing.
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 once-daily dosing.
Razadyne ER was developed under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group. It is approved for the treatment of mild to moderate Alzheimer’s disease in 24 countries.