Reminyl (galantamine hydrobromide)
Company: Janssen Pharmaceutica
Approval Status: Approved February 2001
Treatment for: Mild to moderate dementia of the Alzheimer's type
Areas: Neurology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
Reminyl is an Alzheimer's treatment derived from the bulbs of the daffodil, Narcissus pseudonarcissus. It is believed that neurons producing the neurotransmitter acetylcholine degenerate in the brains of patients with Alzheimer's disease. This loss of acetylcholine has been correlated with decreased cognitive function (thinking, remembering and reasoning). Reminyl works to increase the concentration of acetylcholine by blocking the action of acetylcholinesterase, an enzyme that catalyzes the hydrolysis (break down) of acetylcholine.
An estimated four million Americans have Alzheimer's disease -- a progressive loss of cognitive function so severe that it interferes with an individual's ability to function. The number is expected to grow to 14 million by the middle of the next century. The disorder is the third-most expensive illness in the United States, behind only heart disease and cancer.
Reminyl was developed by the Janssen Research Foundation under a co-development and licensing agreement with the UK-based Shire Pharmaceuticals. The drug will be marketed by Janssen Pharmaceutica and Ortho-McNeil Pharmaceutical in the United States.
Clinical Results
In trials ranging from 12 to 26 weeks, the effectiveness of Reminyl was measured using two primary tools. Subjects' abilities in terms of memory, orientation, reasoning and language were assessed using the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog). Across all trials, results demonstrated that more subjects taking Reminyl showed significant improvement in their cognitive performance than subjects taking placebo.
The second primary measure of effectiveness was the Clinician's Interview-Based Impression of Change plus Caregiver Information (CIBIC-plus), which provides an overall assessment of patient functioning - including behavior, organized thinking and activities of daily living (such as dressing, eating and managing family finances). The CIBIC-plus results from all trials also showed that the overall scores for subjects taking Reminyl were statistically superior to placebo.
Side Effects
Adverse events reported with Reminyl use include (but are not limited to) the following:
- Nausea
- Vomiting
- Diarrhea
- Anorexia
- Weight loss
The most frequent adverse events associated with the use of Reminyl can be minimized by following the recommended dosage and administration.
Because this list is not all-inclusive, please consult a physician to discuss any side effects and the individual appropriateness of the drug.
Mechanism of Action
Galantamine, a tertiary alkaloid, is a competitive and reversible inhibitor of acetylcholinesterase. While the precise mechanism of galantamine's action is unknown, it may exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. If this mechanism is correct, galantamine's effect may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. (from Reminyl Prescribing Information).
Additional Information
Reminyl is given in a tablet formulation, with 4 mg, 8 mg or 12 mg dosages. The drug should be taken twice a day, preferably with morning and evening meals.
For more information on Reminyl, please visit Janssen Pharmaceutica.
Additional information on Alzheimer's disease can be obtained by visiting the Alzheimer's Association.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
