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The extract, marketed by Valensa as USPlus, was shown to be comparable to Permixon, a saw palmetto-based medicine in Europe.
February 16, 2023
By: Mike Montemarano
A preclinical comparison study showed that a novel saw palmetto extract marketed by Valensa International as USPlus had mechanistic enzyme activity associated with prostate health and hair loss prevention similar to that of established versions of saw palmetto extracts. In the study, researchers compared two standardized lipidosterolic extracts of saw palmetto (Serenoa repens). USPlus, a proprietary ultra-high pressure supercritical carbon dioxide extract, was compared to Permixon, a hexanic extract of saw palmetto marketed as a drug in Europe for benign prostatic hyperplasia (BPH), for both 5aR inhibition activity and lipid profiles. The two extracts had nearly-identical inhibition curves and comparable potency measurement values for both 5aR-1 and 5aR-2, which convert testosterone to dihydrotestosterone. Both extracts also had comparable lipid profiles based on total fatty acid levels, weight/weight comparisons of individual fatty acids, and individual fatty acid ratios to lauric acid. Permixon meets standards set by the European Medicines Agency (EMA) for a well-established use medicinal product. “USPlus meets the standard set by the United States Pharmacopoeia (USP) monograph for authenticity and purity of a supercritical carbon dioxide extract of saw palmetto,” said Margaret H. Dohnalek, PhD, chief science officer and senior vice president of research and innovation for Valensa International. The authors of the study concluded that USPlus offers a comparable standardized lipidosterolic saw palmetto extract for men with lower urinary tract symptoms (LUTS) due to enlarged prostate in regions such as North America where Permixon is not available. Another finding of the study is the equally strong inhibition of 5aR-1, which is predominantly found in skin and hair. Through inhibiting this enzyme, production of dihydrotestosterone (DHT) is reduced. This can slow down androgenic-mediated hair loss associated with testosterone’s conversion to DHT. A Staple of Healthy Aging According to NIH’s National Institute of Diabetes and Digestive and Kidney (NIDDK) approximately 14 million men in the U.S. have lower urinary tract symptoms associated with an enlarged prostate (BPH), and 50% of men between 50 and 60 are affected by BPH, the risk of which increases with age. “Saw palmetto (Serenoa repens) has been a staple botanical for men’s urological health,” said Dohnalek. “However, products in the market are inconsistent and many do not provide an extract with the fatty acid profile and dose for clinical effectiveness. Valensa’s USPlus saw palmetto, a patented pure lipidosterolic extract, delivers the mechanism of action and represents the lipid profile shown by the global body of literature to provide specific support to the prostate in men exhibiting lower urinary tract symptoms.” Liposterolic extracts of saw palmetto with a minimum 80% total fatty acids that meet the USP or EU monograph, when taken at efficacious dosages of 320 mg daily, have been associated with reduced urinary urgency and frequency in men over the age of 50. in the inhibition of 5aR-1 and 5aR-2, which prevent the conversion of testosterone into its active metabolite, have been shown to further impact prostate enlargement. USPlus is the first and only USP-verified saw palmetto ingredient, Valensa reports. The quality, safety, and ecological footprint of the ingredient is represented by the USP Dietary Ingredient Verification Program, FDA cGMP compliance, and sustainability practices at the company’s protected saw palmetto grove.
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