The California-based company's ingredient is a combination of patented polymethoxylated flavones from orange peel and a proprietary extract from phellodendron amurense .
Next Pharmaceuticals claims the ingredient lowers "bad" LDL cholesterol by 45 percent and increases HDL cholesterol by 12 percent.
According to Frost & Sullivan, health professionals generally recommend statin drugs for reducing cholesterol, which tend to have no effect on HDL or "good" cholesterol.
These drugs, which Frost & Sullivan says are recommended even for patients with slightly elevated cholesterol, include Lipitor, Zocor and Pravachol.
Dietary supplement marketers argue it may be more appropriate for a person with only a moderately elevated LDL cholesterol level to take non-drug natural products due to the fact statins can have negative side effects and do not positively impact HDL cholesterol.
The market for heart health supplements, according to Frost & Sullivan, stood at $0.8b in the United States in 2005 and is predicted to grow to $1.81b by 2012.
The natural ingredients found in many dietary supplements claiming to lower cholesterol are garlic, vitamin E, fenugreek, artichoke extract, guggulipid , red yeast rice, pantethine , plan sterol/stanol and polymethoxylated flavones and phellodendron extracts.
Side effects have been associated with some of these ingredients.
Next Pharmaceuticals announced in December the results of a clinical trial it said was being submitted for publication in early 2007 - though it did not indicate the nature of the publication.
According to the company, the double-blind placebo-controlled clinical trial with 80 subjects showed Flavoxine significantly increased HDL cholesterol, while significantly reducing LDL cholesterol and triglycerides.
The increase in HDL cholesterol in the overweight group compared to the placebo group was P<0.001.
The decrease in LDL cholesterol between the groups was P<0.01.
Next also claims Flavoxine reduced C-reactive protein, an indicator of inflammation associated as a positive risk factor for coronary artery disease.
The study was conducted through the Department of Biochemistry, University of Yaounde in Cameroon, and Next said it is looking to replicated the trial in the U.S. with an academic institution and under a National Institutes of Health grant.