Nexrutine^® is a patent-pending plant extract developed from the phellodendron tree (Phellodendron amurense). This tree has been a rich source of traditional medicine in Asia for more than 1500 years. The proprietary Nexrutine^® extract, developed by Next Pharmaceuticals, Inc. (www.nextpharmaceuticals.com), is unique in its ability to aid in natural pain management due to exercise and over-exertion.

Nexrutine^® may help to prevent certain enzymes from causing inflammation without interfering with key enzymes that are necessary for keeping the stomach lining healthy. Nexrutine^® appears to have multiple mechanisms by which it exerts its beneficial effects.

An extensive literature review of the chemical constituents plus the parent plant's use for hundreds of years suggests that this material is safe for its intended use. In addition, an acute toxicity study in rats (5g/kg) with 14-day observation revealed no untoward effects from Nexrutine^®. In a recent clinical trail with Nexrutine^®, no significant side effects were recorded. Recent news regarding certain anti-inflammatory products suggests that some may increase the risk for cardiovascular problems in patients at risk for cardiovascular disease. But the potential anti-inflammatory effects of Nexrutine^® may actually promote cardiovascular health.

Clinical research has shown that one of the major active components of Nexrutine^® does not cause platelets to aggregate. The plant source of Nexrutine^® has been used safely for thousands of years for various conditions in traditional medicine. Nexrutine^® is safe and because of its unique mechanism of action, does not increase the risk for cardiovascular problems and may have cardiovascular protective properties. No side effects are expected at the recommended human dosage.

A double-blind placebo-controlled trial investigating the benefits of Nexrutine^® in 28 subjects with serious joint pain was completed in early 2004. The group on Nexrutine^® significantly improved on total quality of life measurements whereas the placebo group did not. The total post-treatment scores on the SF-36v2 Quality of Life instrument were improved significantly from the pre-treatment scores in the Nexrutine^® group for Role Physical, Vitality, Mental Health and Mental Component Summary. Of importance, the Nexrutine^® group showed significant improvements on these measures over the course of the study whereas there were no changes in the placebo group.

Nexrutine^® has been shown in an in-home-use-trial, the type of trial used to demonstrate safety and efficacy for over-the-counter (OTC) drugs, to be a safe, effective and rapidly acting dietary supplement which helps avoid or relieve the general aches and pains associated with physical activity or over-exertion.

Fifty-three subjects were treated with Nexrutine^® for two weeks. The recommended dosage was 250-mg Nexrutine^® three times daily.

Post-trial analysis revealed an excellent agreement (79%) with the pretrial concept that Nexrutine^® helps avoid or relieve general aches and pains associated with physical activity or over exertion. Overall effectiveness was reported by 72% of the patients. The efficacy parameters for Nexrutine^® included the following; eases soreness in joints and muscles, and makes everyday activities more comfortable. Additionally, the subjects were comfortable using the product. No significant side effects were reported. Nexrutine^® was judged to be gentle on the stomach by 86% of the subjects. In addition to the above, Nexrutine^® has been tested in a 370-person open trial. Ninety-one percent (91%) reported beneficial effects including reduction in pain and/or inflammation and an increase in mobility/flexibility.