Valensa International’s signature joint-health compound, FlexPro MD has been certified as a functional ingredient for Functional Health Foods in the Republic of Korea.
According to Ministry of Food and Drug Safety in Korea, FlexPro MD is approved in compliance with Articles 14 and 15 of the Functional Foods Act, and products carrying the formulation can make a functional claim to maintain healthy joints.
The certification was awarded based on the strength of two mechanistic studies and two human studies of FlexPro MD – a proprietary and multi-patented blend of phospholipid-bound omega 3 EFAs (from krill oil), Valensa’s Zanthin natural astaxanthin and Valensa’s Flexonic proprietary lower molecular weight hyaluronic acid.
According to Stephen Hill, Vice President product technology quality and regulatory for Valensa, the Korean functional ingredient certification is a culmination of a multi-year project to design and conduct the clinical trials, manufacture trial materials, test the actives using KFDA standard methods. The formula and each of the ingredients contained within were scrutinised by the MFDS and the Novarex Co R&D Centre, for safety and efficacy. The company partnered with Novarex for the registration process.
The product delivery form, small dose and effectiveness also improves compliance and customer repeat purchases
In the mechanistic study, the formula was shown to significantly inhibit NF-κB activation, expression levels of pro-inflammatory markers such as, TNF-α, IL-6 and IL 1β and matrix-degradation enzymes MMP1 and MMP2. In the second study, subjects administered FlexPro MD showed significantly ameliorated joint pain and decreased severity of articular cartilage destruction.
The first human study was conducted by Valensa in the US and showed FlexPro MD (one small softgel) outperformed a standard full dose of glucosamine and chondroitin for providing joint comfort by three times. A new 12-week, multi-center human clinical trial with 100 participants was also conducted in Korea to support the application.
Results showed a significant improvement in self-reported (VAS) and physician-assessed (K-WOMAC) joint pain assessments compared to placebo. The study also found significant differences in total joint health (pain, stiffness, physical function). The study that will be published later this year saw some patients on FlexPro MD experience 50% or greater reduction in joint discomfort over 12 weeks.
“FlexPro MD covers the critical factors of joint health care that consumers seek,” said Umasudan (Uma) Pal, CEO of Valensa International. “These factors include mediating joint discomfort, managing inflammatory cascades, improving joint stiffness and overall joint physical function. The product delivery form, small dose and effectiveness also improves compliance and customer repeat purchases. FlexPro MD formulation is available for discerning brands that want to differentiate their joint health portfolio with a clinically studied formula that can also be customised for their customer segments. Valensa is evaluating licensees in specific channels and markets.”
