Razadyne is new name for Reminyl

To support safe prescribing and dispensing for patients with Alzheimer's disease, Ortho-McNeil Neurologics, Inc., announced today that REMINYL (galantamine hydrobromide) will now be marketed in the U.S. under the new product trade name RAZADYNE (galantamine hydrobromide). The extended release formulation of galantamine, approved in December 2004, will be marketed as RAZADYNE ER (galantamine hydrobromide). The products are indicated for the treatment of the symptoms of mild to moderate Alzheimer's disease.

Reminyl is manufactured by Johnson & Johnson. The drug has been mired in a controversy leading to speculation of a Reminyl recall. Investigations by health authorities are still in progress.

According to the firm, the name is being changed to help avoid confusion with the diabetes drug AMARYL (glimepiride), which is marketed by Sanofi-Aventis. Ortho-McNeil Neurologics, Inc., began working closely with the U.S. Food and Drug Administration (FDA) since learning of several reports of prescribing and dispensing errors between REMINYL and AMARYL.

"Our top priority is to ensure the well-being of our patients," said Joseph Hulihan, M.D., vice president, Medical Affairs, Ortho-McNeil Neurologics, Inc. "Through ongoing discussions with the FDA, we agreed that the best way to avoid future dispensing errors was to change the name of REMINYL which came onto the market nearly six years after AMARYL."

"Medication errors occur frequently among elderly patients, and the need for clarity in product names is particularly important for patients with Alzheimer's disease and their caregivers," said Stephen Aronson, M.D., clinical assistant professor, University of Michigan Medical School. "I believe this change is key to keeping safety at the forefront for my patients."

Approximately two million patients have been treated with REMINYL to date. According to reports submitted to the FDA and the U.S. Pharmacopoeia since REMINYL was introduced in the United States, a few prescriptions for REMINYL have been incorrectly written, interpreted, labeled or filled, leading to confusion between REMINYL and AMARYL. The accidental administration of AMARYL to patients with Alzheimer's disease who did not have diabetes mellitus resulted in serious events, including severe hypoglycemia and – in two cases – death.

The immediate release formulation bearing the new name, RAZADYNE, will be available in pharmacies beginning in July 2005. Prescriptions written before that time will be filled with REMINYL. Product bearing the new name, RAZADYNE ER, the extended release formulation, will be available in pharmacies beginning in mid-May 2005.

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. 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.