RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Zylera Pharmaceuticals announced today that new RELAMINE(TM) (chondroitin 300mg, glucosamine 400mg and primorine(TM) 425mg), a novel, prescription treatment for osteoarthritis, is now available for patients throughout the U.S. RELAMINE is the first and only prescription product that contains pharmaceutical quality glucosamine, chondroitin and primorine. RELAMINE helps to reduce joint swelling and control pain while slowing the onset and progression of osteoarthritis.
"We are pleased to announce the availability of RELAMINE to the millions of Americans living with the pain and swelling associated with osteoarthritis," said Dr. Philip Tabbiner, chief executive officer of Zylera Pharmaceuticals. "RELAMINE can help reduce the swelling in the joints, control joint pain associated with osteoarthritis, reduce the onset and progression of osteoarthritis and can be used in combination with other available treatments."
According to Hayes Wilson, M.D., Chief of Rheumatology, Piedmont Hospital and National Medical Advisor, Arthritis Foundation, "Arthritis is one of the most debilitating illnesses in the U.S. and the nation's leading cause of disability. There is a significant unmet medical need for safe and effective therapies for the treatment of the pain and inflammation associated with arthritis and osteoarthritis in particular."
Osteoarthritis is the most common form of arthritis and is characterized by chronic and often disabling pain and stiffness of one or more joints, particularly those of the fingers, spine, hips, knees, and feet. According to the Arthritis Foundation, arthritis results in 39 million physician visits with more than a half million hospitalizations, and limits everyday activities such as walking, dressing and bathing for more than seven million Americans.
There have been several large clinical trials that show the benefits of chondroitin and glucosamine in treating the pain associated with osteoarthritis. One such study, the Glucosamine/chondroitin Arthritis Intervention Trial (GAIT), published in the February 23, 2006 edition of the New England Journal of Medicine, was designed to rigorously evaluate the efficacy and safety of these agents alone and in combination when taken over a 24-week period.
The study measured the effects of taking glucosamine alone, chondroitin alone, a glucosamine-chondroitin combination or celecoxib alone against placebo in 1,258 people with mild or moderate-to-severe pain from knee osteoarthritis. The authors noted that there is substantial variation (41% - 108%) between the content listed on the label of over-the-counter products and the actual content in the product. Therefore, they used a product manufactured under strict pharmaceutical regulations.
The results of this study found that patients with moderate-to-severe pain had significant improvement in osteoarthritis of the knee after 24 weeks of treatment with chondroitin and glucosamine.
RELAMINE (chondroitin 300mg, glucosamine 400mg and primorine 425mg) reduces the inflammation of osteoarthritis, reduces the pain associated with it and may slow the onset and progression of OA. Glucosamine and chondroitin sulfate are found naturally in the body. Glucosamine is a form of amino sugar that is believed to play a role in cartilage formation and repair. Chondroitin sulfate is part of a large protein molecule that gives cartilage elasticity. Primorine, a novel carbonyl-trapping combination, is used to reduce the toxic effects of highly reactive carbonyl-containing compounds, which are produced under conditions of oxidative stress. Oxidative stress causes cartilage degeneration and chondrocyte aging. Zylera's proprietary novel carbonyl-trapping agent, primorine, enables its products to react with, or "trap," toxic carbonyl groups such as aldehydes and ketones that the body produces under conditions of oxidative stress to form less-harmful derivatives that are then eliminated through the kidneys.
Previous studies have shown that some people with mild to moderate osteoarthritis taking either glucosamine or chondroitin sulfate reported pain relief at a level similar to that of non-steroidal anti-inflammatory drugs, such as aspirin and ibuprofen. Some research indicates that glucosamine or chondroitin sulfate might also slow cartilage damage in people with osteoarthritis.
RELAMINE is not for everyone. RELAMINE may increase insulin resistance and consequently affect glucose tolerance. People with diabetes who take glucosamine tablets will need to monitor their blood glucose and may need to adjust their blood glucose medication to effectively manage their blood sugar levels. There are no known drug, nutrient, food or herb interactions with chondroitin. The most common side effects seen with glucosamine and chondroitin were mild gastrointestinal complaints, including heartburn, epigastric distress, nausea and diarrhea.
About Zylera Pharmaceuticals
Zylera is a specialty pharmaceutical company focused on developing medications that will treat multiple diseases arising within the inflammation and immunosuppressive pathways. Its near-term pipeline includes products for diabetes, elevated cholesterol, osteoporosis, and osteoarthritis, utilizing proprietary and patented chemical entities designed to restore key metabolic processes. Chief among these is Cytac, a carbonyl-trapping technology. Zylera, a wholly owned subsidiary of TRx Pharma(www.trxpharma.com), is located in Research Triangle Park, NC.