Next Pharmaceuticals introduced Nexrutine to the market four years ago but since the company's main emphasis is on research and development, president and CEO Bob Garrison told NutraIngredients-USA that the ingredient has not been marketed very aggressively.
At present, it is contained in about half a dozen dietary supplements, including Natrol's FeelAnew and Nature's Sunshine's Triple Release. It is also available from health stores as a stand-alone supplement.
But the opportunities for the Californian company in the light of the Vioxx withdrawal last September are too great ignore; it is intensifying its sales and marketing efforts in the US and is actively seeking a partner to facilitate a roll out in Europe.
Similarities to Vioxx and other Cox-2 inhibitors stem from the fact that it prevents the release of the Cox-2 enzyme, but it does so not by inhibiting the enzyme itself but acting on the gene that expresses the enzyme.
While the litigation over Vioxx has centered on the link between the drug and thrombosis, said Garrison, Nexrutine has been shown to have an anti-thrombosis mechanism.
He drew attention to a study published in Thrombosis Research (106; 2002; 223-227) indicating that berberine, the primary anti-inflammatory in Nexrutine, might inhibit arachinodonic acid metabolism in rabbit platelets; and another in Acta Physiologica Sinica (2004 Apr; 25(4): 496-502) investigating its effect on impaired glucose tolerance and insulin secretion in rats.
Human clinical trials have also been carried out to ascertain safety.
"There is a wonderful story to be told here in the light of Vioxx," Garrisont said.
Nexrutine is derived from the bark of the phellodendron tree, which has been used in Chinese medicine for more than 1,500 years. The company discovered that of the four fractions of the bark, one has strong anti-inflammatory properties and another anti-anxiety properties. The ingredient was therefore developed to combine these two fractions.
Of the anti-anxiety element, Garrison said: "If you reduce anxiety in a person experiencing pain, you will reduce their perception of pain. Pain is a strange thing to address, and everyone reacts differently."
Unlike glucosamine and chondroitine, the two most popular a joint health ingredients, it does not rebuild the tissue but can be used in combination with them, as is the case in Natrol's FeelAnew.
In the past five months, there has been a huge movement of people searching the web for alternatives to Cox-2 inhibitors. "People are concerned about Vioxx and are looking for something that has reasonable science that suggests it is safe and that it works," said Garrison.
As Next Pharmaceutical is a private company, he did not comment on turnover, but said that he expects to see double or triple sales of Nexrutine.
As to other projects in the pipeline, the company is also embarking on a research project with the UK's University of Surrey to look at the mechanisms of action of orange oil in stabilizing inflammatory pathways and preventing the onset of athliosclerosis.
Called Citri-Z, the oil is derived from a particular type of orange found in Florida. The company has spent the last two years perfecting the manufacturing process, and although at present the difficulty of the process means it can yield only small amounts, it could be on the market by the end of this year.
Research will continue beyond the soft launch, said Garrison.