Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Neurology | Family Medicine
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Reminyl (galantamine hydrobromide)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Janssen Pharmaceuticals
Approval Status: Approved February 2001
Treatment Area: Mild to moderate dementia of the Alzheimer's type
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.
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
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.
Adverse events reported with Reminyl use include (but are not
limited to) the following:
- Weight loss
The most frequent adverse events associated with the use of
Reminyl can be minimized by following the recommended dosage and
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
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
Additional information on Alzheimer's disease can be
obtained by visiting the Alzheimer's Association.