SCOTTSDALE, Ariz., Feb 01, 2006 /PRNewswire via COMTEX/ -- Limbrel, the first prescription product developed to safely meet the nutritional requirements of patients with osteoarthritis (OA), is being introduced nationally by Primus Pharmaceuticals, Inc. OA is the most common form of arthritis, and currently afflicts more than 20 million Americans. Physicians have been prescribing traditional NSAIDs and COX-2 inhibitors for patients, but ongoing revelations about possible serious side effects associated with these drugs over the last 18 months have left many patients and physicians with increasing safety concerns.
Limbrel represents an entirely new approach to managing OA with a breakthrough in patient safety. It is regulated as a medical food, which means it has been developed to meet the specific nutritional needs of patients with OA and can only be taken under the supervision of a physician. Additionally, its ingredients meet the strict regulatory safety standard of Generally Recognized as Safe (GRAS). The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition and agreement on that safety by experts in the field. In addition, GRAS safety status is supported by widespread consumption of key ingredients by millions of people over generations of time.
"After more than eight years in development and one year in limited markets, Limbrel represents a safe and totally new approach for millions of OA patients," said Bruce Burnett, PhD, Director of Medical Education and Scientific Affairs for Primus Pharmaceuticals, and former instructor at Yale University School of Medicine. "Because Limbrel's ingredients are not synthetic or artificial, and they balance the body's natural metabolic processes related to osteoarthritis, it is reassuring to physicians who have become alarmed at the serious side effects uncovered in past OA prescription drug products."
Dr. Brian J. Cole*, orthopedic surgeon, Associate Professor and Section Head of the Cartilage Restoration Center at Rush University Medical Center in Chicago, commented, "With the COX-2 product recalls, both doctors and their patients are searching for something truly safe. I am glad Limbrel is now available to orthopedists nationwide because we need something effective that addresses the concerns of our patients. The bottom line is: Limbrel works when appropriately recommended and I have had no serious side effects compared to other prescription products. Its regulatory classification as a medical food is also reassuring to patients."
Dr. Anthony K. Hedley*, world renowned total joint surgeon and former faculty member of UCLA's Medical School, commented about Limbrel, "The product is so effective that I prescribe it to my patients and use it myself. It's unique for me to experience something good at the same time as my patients do."
OA is more than a degenerative disease. OA is also a metabolic disease which results from changes in certain natural processes usually triggered by injury or by wear and tear associated with the aging process. This leads to the breakdown and degradation of cartilage in the joints. The process is worsened by deficiencies in certain nutrients such as selected flavonoids, antioxidants and essential fatty acids, which help to regulate the inflammatory process. The deficiencies of these nutrients mean that certain inflammation and oxidation pathways are not functioning normally. The end results are discomfort, stiffness, and loss of movement for OA sufferers.
In both clinical studies and daily prescription usage under a doctor's care, Limbrel has consistently demonstrated significant improvements in the validated OA measures of discomfort, stiffness and mobility. Limbrel contains flavocoxid, a patent-pending blend of natural ingredients, comprised primarily of the concentrated flavonoids baicalin and catechin, which are recognized for their anti-inflammatory and antioxidant properties. Flavonoids are healthful ingredients found in colored vegetables, fruits, cocoa, red wine and green tea, and have been studied extensively for a wide variety of health benefits. Limbrel delivers antioxidant benefit in a highly concentrated form, which cannot be achieved simply by changing one's normal diet.
As the only marketed prescription product with COX & LOX Dual Inhibition action balancing COX-1/COX-2 (cyclo-oxygenase) metabolism and inhibiting the 5-LOX (lipoxygenase) inflammatory pathway, Limbrel directly addresses the dietary imbalances of OA rather than merely focusing on the symptoms of disease. The side effects of Limbrel have been found to be similar to placebo in clinical studies with only slightly more minor side effects of nausea and diarrhea. There has been no serious adverse event reported to-date in actual in-market usage of Limbrel by over 23,000 OA patients. For more information on Limbrel, please visit http://www.limbrel.com.
About Primus Pharmaceuticals, Inc.
Primus is the first specialty pharmaceutical company to focus on prescription metabolic products dedicated to improving patient quality of life without compromising safety. Primus develops branded prescription drugs and medical foods that are patented and effective in chronic or recurring diseases. The Company's unique approach is to develop first-line medical food products formulated to restore metabolic processes at the disease source rather than focusing on symptoms. Primus promotes to targeted physician audiences and extends its sales reach and clinical capabilities through strategic partnerships. Primus is privately held and based in Scottsdale, AZ. http://www.primusrx.com
Limbrel is the first prescription product developed and formulated specifically to safely meet the distinctive nutritional requirements of patients with OA. Limbrel contains flavocoxid, a proprietary blend of natural flavonoid ingredients from food sources that meet the regulatory safety standard of generally recognized as safe (GRAS). Flavonoids are healthful ingredients found in colored vegetables, fruits, cocoa, red wine and green tea. Limbrel works by restoring the body's normal metabolic inflammatory processes through the dual inhibition (COX + LOX) of excess arachidonic acid metabolization and antioxidant action. Clinical studies have shown Limbrel to be effective in the dietary management of OA. Limbrel is manufactured according to current Good Manufacturing Practices (cGMP) for prescription drugs, even though only food cGMP is required. It is available by prescription only, as Federal regulations require that Limbrel be used only under a physician's supervision. http://www.limbrel.com
* Doctors Cole and Hedley are medical advisors to Primus Pharmaceuticals, Inc.