New Clinical Study Shows Limbrel as Effective as Naproxen for Knee Osteoarthritis
"In this study, the Limbrel and naproxen groups performed nearly identically, showing significant overall improvements in conventional osteoarthritis efficacy measures, including physician and subject global assessments, and WOMAC, a key measure of mobility, stiffness and joint discomfort," said the lead author Robert Levy, M.D., a rheumatologist for over 30 years and director of clinical development at Primus Pharmaceuticals. "This suggests that Limbrel can be an effective prescription product for the management of osteoarthritis."
Osteoarthritis (OA) is the number one cause of disability in the United States. About 25 million Americans, or 1 in 8 adults, have OA, the most common form of arthritis. Osteoarthritis was commonly considered to be a wear-and-tear or aging disease. However, recent scientific evidence has pointed out the metabolic factors involved in worsening the damage to joints over time. Limbrel is the first prescription product that addresses the metabolic processes of osteoarthritis, using all natural, highly concentrated nutritional (flavonoid) ingredients.
"I have had good success with Limbrel in my practice. It provides significant improvements for arthritis patients without the side effects of gastrointestinal (GI) complications, increased blood pressure or kidney problems often associated with NSAIDs such as naproxen. This is very important because with Limbrel, I can offer it to patients with less worries," said Dr. Vijay Vad, attending physiatrist at Hospital for Special Surgery, Professor at Weill Medical College of Cornell University in New York City and author of the book, Arthritis Rx. "For osteoarthritis patients, simple movements like walking, getting into cars, or just lying down become limited or painful. Not everyone responds to Limbrel, but for those who do, what they get back are not just their physical movements, but also their ability to interact with their family and enjoy life again." (Dr. Vad does not have any financial ties to Primus, the company that markets Limbrel.)
Joint inflammation is mediated via several enzyme systems, cyclooxygenase (COX-1, COX-2) and 5-lipoxygenase (5-LOX). Together, these produce a variety of molecules, including prostaglandins, prostacyclins and leukotrienes, which promote inflammation at the cellular level in joints and are involved in important physiological processes such as GI protection (stomach lining protection). Most experts agree these molecules should be maintained in proper balance. However, conventional anti-inflammatory drugs tend to preferentially inhibit one or another of these enzyme pathways resulting in an imbalance of end products that may be responsible for their side effects.
Limbrel's approach is completely different. Instead of strong preferential inhibition of only one pathway, Limbrel more evenly manages the activities of both COX pathways as well as the 5-LOX pathway. Thus, it regulates prostaglandin and leukotriene production to manage inflammation using therapeutic nutritional ingredients in a balanced way, while minimizing side effects by not interfering with the physiological functions.
Detailed Study Results
In this multi-center, double-blind, active comparator controlled clinical study, 103 patients with moderate-severe knee osteoarthritis were randomized to receive either Limbrel (flavocoxid) 500 mg twice a day or naproxen 500 mg twice a day for one month. Primary endpoints of the study were conventional efficacy measures: Western Ontario and McMaster's University Osteoarthritis Index (WOMAC), physician global assessment of disease, and subject global assessment of disease and discomfort. Both Limbrel and naproxen groups showed statistically significant within-group improvements (p less than 0.001). Using the Fisher's exact test to compute improved vs. not improved, 87 percent of patients taking Limbrel noted improvement, similar to 88 percent in the naproxen group. No statistically significant differences were found between groups for any of the efficacy parameters measured, although there was a slight trend toward greater improvement in physician global assessment of disease in the Limbrel group and WOMAC in the naproxen group. Adverse events reported in both groups were mild and similar, with a slight trend toward more frequent edema and nonspecific musculoskeletal events in the naproxen group. One limitation of the study is that it was too short to demonstrate long-term safety differences between Limbrel and naproxen. A copy of the study is available at www.limbrel.com/professional/clinical.
For more information on Limbrel, please visit www.limbrel.com.
Limbrel is a prescription medical food product for the clinical dietary management of the metabolic processes of osteoarthritis.
(1) Levy R, Saikovsky R, Shmidt E, Khokhlov A. 2007. Safety, efficacy and acceptability of flavocoxid (Limbrel(TM)) compared with naproxen in subjects with osteoarthritis of the knee: a pilot study. Osteoarthritis and Cartilage. 15(suppl B):B91
About Primus Pharmaceuticals, Inc.
Primus is the first 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 proven safe and effective in chronic or recurring diseases. The Company's needs-based process to develop first-line prescription products formulated to restore metabolic processes at the disease source (rather than masking symptoms) is novel and proprietary. Primus promotes to targeted physician specialists and extends its sales reach and clinical capabilities through strategic partnerships. All products are protected by composition of matter patents and other intellectual property. Primus is privately held and based in Scottsdale, AZ. For more information, visit www.primusrx.com.
This press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors. Primus cautions that any forward-looking information is not a representation or guarantee of future performance, and Primus assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Amendola Communications for Primus Pharmaceuticals
Jodi Amendola, 480-664-8412 x 11
Jan Shulman, 480-664-8412 x 12
Michael Martin, 480-483-1410
Posted: November 2007