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March 1, 2001
Reminyl® (galantamine hydrobromide) - a new treatment for mild to moderate Alzheimer's disease derived from the bulbs of daffodils - was approved today by the U.S. Food and Drug Administration (FDA).
Data from four placebo-controlled, double-blind clinical trials involving more than 2,650 patients show that Reminyl can have a beneficial effect on patients' daily function and ability to think. To be available by prescription in May, Reminyl was developed by the Janssen Research Foundation under a co-development and licensing agreement with the UK-based Shire Pharmaceuticals Group plc.
An estimated 4 million Americans have Alzheimer's disease, a progressive loss of cognitive function (thinking, remembering and reasoning) so severe that it interferes with an individual's ability to function. That 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.
"Alzheimer's disease patients progressively deteriorate," says Gary Small, MD, director of the Center on Aging and professor of psychiatry and biobehavioral sciences at the University of California in Los Angeles. "But the studies show that Reminyl can benefit many individuals with the disease. In studies lasting up to six months, many patients' symptoms initially improved or stabilized, and even when they begin to decline, they remained better than those who were treated with placebo [inactive medication]."
In studies ranging from 12 to 26 weeks, the effectiveness of Reminyl was measured using two primary tools. Patients' abilities related to memory, orientation, reasoning and language were assessed using the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog). Across all studies, the results consistently demonstrated that more patients taking Reminyl showed significant improvement in their cognitive performance than those receiving 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 studies also showed that the overall scores for patients taking Reminyl were statistically superior to placebo.
Reminyl will be available in 4 mg, 8 mg or 12 mg tablets. It should be taken by patients twice a day, preferably with meals. The approved product labeling recommends that physicians start by prescribing 8 mg of Reminyl per day (in two divided doses), then increase the dose to 16 mg after at least four weeks. Physicians have the flexibility to increase the daily dose to 24 mg after an additional four weeks.
With this recommended dosing regimen, the percentage of patients who dropped out of the clinical research due to side effects after taking Reminyl (7-10%) was comparable to the discontinuation rate for individuals receiving placebo (7%). Overall, the most common side effects experienced by patients who followed the recommended schedule for Reminyl were primarily gastrointestinal in nature. Side effects that occurred in 5% or greater of patients included nausea, vomiting, anorexia, diarrhea and weight loss.
"Reminyl is a major addition to Janssen's growing CNS [central nervous system] franchise. We are committed to improving the lives of both Alzheimer's disease patients and their caregivers," says Luc Truyen, MD, PhD, global medical leader for Reminyl with the Janssen Research Foundation. "In fact, support for family caregivers will be an important element of the educational programs we will initiate in conjunction with the introduction of Reminyl."
Reminyl also has been approved in 21 other countries to date, including most major European markets. Reminyl will be marketed by Janssen Pharmaceutica and Ortho-McNeil Pharmaceutical in the United States, Janssen-Ortho in Canada (approval pending) and Janssen-Cilag elsewhere - with the exception of the United Kingdom and Ireland, where it is registered and marketed by Shire under a co-promotion agreement with Janssen-Cilag.
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