(Irvine, CA)– A new study has demonstrated that the all natural anti-inflammatory and pain reliever Nexrutine does not cause gastrointestinal (GI) irritation, a common side effect of aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, Celebrex®, and Vioxx®.
Nexrutine, developed by Next Pharmaceuticals, Inc, is a dietary supplement ingredient consisting of a patent-pending plant extract from the bark of Phellodendron trees common in Asia. The study, conducted by Product Safety Labs, Dayton, New Jersey, using a well-recognized animal model, supports earlier findings in humans. In a fifty-three-person study 86% of the subjects stated that Nexrutine was gentle on the stomach.
“About 7,500 people in the U.S. die from bleeding caused by both prescription and over-the-counter NSAIDs. Unfortunately, only 1 in 5 get some warning symptoms before such a bleed,” says Dr. Jason Theodosakis, MD, MS, MPH, FACPM, Assistant Professor University of Arizona College of Medicine, author of The Arthritis Cure and one of the world’s foremost authorities on the clinical use of dietary supplements for arthritis.
“In addition to the problems with bleeding, thousands of NSAID users die from kidney and liver damage, high blood pressure, and the medication interactions with other drugs, among other causes. A conservative estimate for overall deaths directly attributable to NSAIDs in the US in 1998 was 16,500 people. This is about as many who died from AIDS or drunk driving and much greater than all deaths from fires, hurricanes, tornadoes, lightning, shark attacks, drowning, accidental shootings, plane crashes, SARS, and terrorism, all combined. We are in need of safe and effective alternatives to NSAIDs and Nexrutine is the most exciting natural alternative to NSAIDs currently being studied,” says Dr. Theodosakis.
In a recent study presented at Digestive Disease Week in Orlando, Fla. May 17-22 arthritic patients who took NSAIDs for more than three months had considerably more intestinal damage than patients taking acetaminophen or nothing for their pain. 58% of high-dose ibuprofen, naproxen, and indomethacin users had damage compared to 17% of non-users.
Nexrutine shows 95% COX-2 enzyme inhibition in human cyclooxygenase-2 (COX-2) assays with less than 10% COX-1 inhibition. Significant inhibition of the COX-1 enzyme leads to GI ulcers. Selectively inhibiting the COX-2 enzyme blocks the formation of certain hormone-like substances called prostaglandins that cause the pain and inflammation responses.
In a two-week human study evaluating the efficacy of Nexrutine to ease soreness in joints and muscles, 72% of the participants said Nexrutine was effective and 86% of the participants said that Nexrutine was gentle on the stomach. Nexrutine is currently under investigation in a placebo-controlled clinical trial to further establish its efficacy.
The plant material from which Nexrutine was developed, the bark of the Phellodendron tree, has been safely used in Asia for more than 1500 years. Additional toxicity testing by Next pharmaceuticals demonstrated that Nexrutine is safe when used as directed. “We are excited about Nexrutine as a safe and effective natural pain management ingredient,” says Bob Garrison, President and CEO of Next Pharmaceuticals. “We believe Nexrutine can play a positive role in cutting health care costs and improving the quality of life.”