PURCHASE, N.Y.--Dec. 10, 2002--
Company Signs Agreement with Comprehensive NeuroScience, Inc. to
Conduct Pivotal Trial to Confirm Findings
Gail Montgomery, President and CEO of Nutrition 21, Inc. (NASDQ: NXXI) announced that the results of a pilot clinical study investigating Zeramax, the Company's chromium picolinate-based supplement as a proprietary nutrition therapy for depression, are being presented today in San Juan Puerto Rico at the 41st Annual Meeting of the Annual College of Neuropsychopharmacology (ACNP).
The study, conducted at the Duke University Medical Center by Dr. Jonathan Davidson, showed significant improvement of the symptoms of depression. The results of the Davidson study have been accepted for publication in the Journal of Biological Psychiatry.
Ms. Montgomery noted, "The Duke University findings, while preliminary, are exciting because they show dramatic drug-like results in treating the largest subtype of depression, with no unwanted side effects. The most effective antidepressant medication for this form of depression, characterized by symptoms of weight gain, carbohydrate craving and chronic fatigue, and thought to affect about 40% of depressed patients, is a class of drugs known as monoamine oxidase inhibitors (MAOIs). Some doctors are reluctant to prescribe MAOIs because of side effects and drug interactions."
According to the National Institutes of Mental Health, over 18 million Americans have a depressive disorder. With the growing recognition that depression is a treatable illness, the anti-depressive therapeutic market has grown to over $12 billion.
Nutrition 21 has also signed agreement with Comprehensive NeuroScience, Inc. (CNS). The White Plains, NY based company operates the largest network of clinical research sites for central nervous system trials in the US. Together the companies hope to confirm the Duke study findings in a large-scale, double-blind, placebo-controlled, multi-site trial. The results are expected to be published in early 2004.
"Given the remarkable promise of Dr. Davidson's research, we identified additional experts in the field of neuroscience and are honored to now collaborate with CNS on the Zeramax Research Program (www.zeramax.com). Nutrition 21's objective is to better understand chromium picolinate's underlying mechanisms of action in brain health and incorporate these findings into the development and responsible marketing of a clinically supported proprietary supplement for promoting good mental health." concluded Montgomery.
Dr. James Ballenger, Senior Vice President of Scientific Development and Director of Drug Development at CNS commented, "At CNS, we're very excited about the potential for chromium-picolinate based approaches to depression. There is a clear need for well-researched products that effectively help patients with depressive symptoms. Should our large-scale studies validate the work of respected researchers and clinicians like Drs. McLeod, Golden and Davidson, then I would predict that Nutrition 21 would be in a very good place in terms of its outstanding science addressing a market much in need of better treatments for people with depression."
About Nutrition 21, Inc.
Nutrition 21 is a leading developer and provider of nutritional products whose health benefits have been substantiated by clinical research. The market leader in nutritional chromium, Nutrition 21 currently holds 35 patents for nutrition products, including 22 for chromium compounds and their uses. More information is available at www.nutrition21.com.
About Comprehensive Neuroscience, Inc.
Comprehensive NeuroScience, Inc. (CNS) is a diversified international company dedicated to expediting the development and appropriate use of new products and services to relieve neuropsychiatric illness. CNS' Vision is the enhancement of the process of knowledge development and implementation in the pharmacological treatment of neuropsychiatric and other brain disorders. CNS' Mission is to identify and reduce key inefficiencies in the development and implementation of clinical pharmacology knowledge by creating products and services that add value to the knowledge process, support drug development, and maximize clinical outcomes. The CNS studies are "set to the highest standards for clinical trials." CNS has partnered with leading pharmaceutical manufacturers worldwide in the development of new treatments for diseases of the central nervous system, including: Eli Lilly, Novartis, Janssen Pharmaceutica, Parke-Davis, Pfizer, Bristol-Myers-Squibb, Organon, Abbott and Hoescht Marion Roussel.
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