Reminyl Approved as Alzheimer's Treatment


by Rich O'Boyle, Publisher
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The US Food and Drug Administration has approved the fourth treatment for those with mild to moderate Alzheimer’s Disease on February 28, 2001. Reminyl (galantamine hydrobromide) can improve memory, behavioral symptoms, and the ability to perform activities of daily living. The drug will be available in pharmacies by May, according to the Janssen Research Foundation, a unit of Johnson & Johnson, the maker of the drug.

The drug does not cure or reverse the disease, but rather slows its progression so that people taking it stay well longer and get worse slower. It is considered to be just as safe and effective as existing treatments, according to an FDA spokesperson.

Overall, three-quarters of the individuals taking the drug in studies saw improvements in one or more of the following: memory, behavior, and activities of daily living, Janssen said. While the improvements were not dramatic, the results were better than those not taking the drug. Individuals who do not take Reminyl (or one of the other available treatments) will see a steady decline in memory, behavior and abilities.

Scientific Studies Reveal Benefits and Risks

According to the results of several clinical studies, individuals taking the new drug showed small but noticeable improvements in memory, orientation, attention, reasoning, language, and activities of daily living. Lesser degrees of improvement were seen in patients with very mild or very advanced dementia. Over time, cognitive abilities in people taking the drug tend to improve, level off and then decline again. The beneficial effects of Reminyl are lost when the drug is discontinued. Individuals who did not take the drug suffered small to moderate declines in cognitive ability over the course of the study.

Twenty to forty percent of people taking the drug experienced side effects such as nausea, vomiting, diarrhea, anorexia, and weight loss. Patients can reduce side effects by taking the drug with food, using anti-nausea medication, and ensuring adequate fluid intake. If the patient must discontinue the drug for several days or longer, they should restart at the lowest possible dose rather than at the last dosage level.

Drugs Under Development

Reminyl is the fourth Alzheimer’s Disease treatment approved for use in the US, after Cognex (tacrine hydrochloride), Aricept (donepezil hydrochloride), and Exelon (rivastigmine tartrate). All belong to the same class of drugs, acetylcholinesterase inhibitors. These drugs increase the concentration of acetylcholine, a brain chemical that helps nerve cells communicate. The longer acetylcholine remains in the brain, the longer those cells can call up memories. These drugs do not "cure" or reverse the underlying dementing process.

US drug companies are working on about two dozen new drugs for Alzheimer’s Disease and other dementias, according to the Pharmaceutical Researchers and Manufacturers Association. Several of them are in advanced stages of testing.

References

1. Janssen News Release: http://www.janssen.com/feature_articles/feature02282001.html

2. Government Approved Prescribing Information and Results of Studies: http://www.janssen.com/products/pi_files/reminyl.pdf

3. Drugs Under Development for Older Americans: http://www.phrma.org/searchcures/newmeds/older2000/olderamericans_newmed.pdf

4. Clinical Trials for Alzheimer’s Disease: http://www.alzheimers.org/trials/index.html

5. U.S. Food and Drug Administration: http://www.fda.gov

6. ElderCare Online’s Medical Research Assistant: http://www.ec-online.net/Assistants/medresassistant.htm

7. News and Research Articles in the ElderCare Forum: http://eldercare.infopop.cc/6/ubb.x?a=frm&s=4956035941&f=2776064151

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