July 16, 2018 07:58 AM Eastern Daylight Time
FAIRFAX, Va.–(BUSINESS WIRE)–Vizuri Health Sciences LLC, a pharmaceutical and over-the-counter (OTC) product development company, today announced the issuance of a U.S. patent that further protects its capsaicin-based product pipeline. Newly issued U.S. Patent 9,956,190, titled “Topical Compositions for Pain Relief, Manufacture and Use,” grants Vizuri exclusive rights to certain high strength topical capsaicin compositions. The patent enhances the protection of the company’s established PainBloc24® OTC capsaicin product as well as the company’s prescription-strength capsaicin formulation products CGS-200-1 (1% capsaicin) and CGS-200-5 (5% capsaicin) that are currently being evaluated in a Phase 2 clinical study for the relief of osteoarthritic knee pain.
William Moore, Ph.D., Vizuri’s President and Chief Executive Officer stated, “We are gratified that the U.S. Patent and Trademark Office has recognized the utility and advantages of our unique capsaicin-containing formulations by granting us this important patent. The patent improves our ability to develop, market and protect highly safe, effective, and non-addictive products for the treatment of numerous chronic pain conditions that affect our aging demographic, and further establishes our competitive position in the marketplace.”
U.S. Patent 9,956,190 further strengthens Vizuri’s enabling-technology patent portfolio, which to-date comprises seven issued and allowed U.S. patents, nineteen issued and allowed foreign patents, and more than thirty-five pending U.S. and foreign patent applications. Vizuri’s intellectual property portfolio also comprises the registered and allowed U.S. trademarks PainBloc24®, Vizuri PainBloc24®, NeuroMax®, and Bloc Around The Clock™.
About Osteoarthritis (OA)
OA is the most common form of arthritis. It most frequently occurs in the knees, hips, and hands. According to the U.S. Centers for Disease Control and Prevention, in the years 2013-2015, an estimated 54.4 million (22.7%) adults had doctor-diagnosed arthritis with higher age-adjusted prevalence in women (23.5%) than in men (18.1%). The prevalence of arthritis is expected to increase in the aging U.S. population and by the year 2040, an estimated 78.4 million (25.9%) adults will have doctor-diagnosed arthritis and two-thirds of those will be women. Also by 2040, an estimated 34.6 million adults (11.4% of all U.S. adults) will report arthritis-attributable activity limitations. Inactivity due to arthritis is associated with conditions such as cardiovascular disease, diabetes, and obesity.
Vizuri’s Patented Products for the Management of Nociceptive Nerve Pain
Affected osteoarthritic joints frequently present with multiple structural alterations to bone and synovial tissue. Synovitis and increased bone marrow lesions have been associated with increased OA pain. Synovium and bone are densely innervated by nociceptive nerve fibers, which become increasingly sensitized (e.g., elicit pain signals in response to normal movements) during the progression of OA disease.
Capsaicin, the naturally occurring substance found in chili peppers that makes them taste spicy hot, exerts an initial pain-dulling sensation through its activation of heat-sensing, transient receptor potential vanilloid 1 ion channels on nociceptive sensory neurons. Prolonged stimulation of these neurons with capsaicin results in sensory neuron desensitization.
Vizuri’s first commercial product is PainBloc24® (www.painbloc24.com), which contains the highest concentration of capsaicin, 0.25%, permitted in a topical OTC analgesic by the FDA, and utilizes patented NeuroMax® formula technology. The innovative PainBloc24® formula contains several safe, non-active ingredients designed to enhance the tolerability and effectiveness of topically applied capsaicin. Vizuri has demonstrated in controlled clinical studies that once- or twice-daily topical application of PainBloc24® for four to seven days can provide a 24-hour reduction in the pain associated with OA of the knee. PainBloc24® is currently available at select drug and grocery retail stores including CVS, Rite Aid, Publix, Kroger, Giant Eagle, and Meijer among others.
The CGS-200 formulations that are being evaluated in the Phase 2 clinical study, VZU00025, contain four or twenty times greater concentrations of capsaicin than does PainBloc24®. CGS-200, like PainBloc24®, utilizes the patented, innovative NeuroMax®formula. Vizuri believes that the PainBloc24® and CGS-200 products hold significant promiseas safer, non-addictive alternatives to opioids, steroids, and NSAIDs for the management of nerve pain in joints in addition to the knee, thereby positioning them more broadly as potential treatments for musculoskeletal pain. Like PainBloc24®, the CGS-200 high-strength topical capsaicin formulations can be self-administered without a need for prior treatment of the affected area with cooling or a with a topical or injected analgesic.
About Vizuri Health Sciences LLC (www.vizuriusa.com)
Privately-owned Vizuri develops and markets new innovative pharmaceutical and OTC products. The products are based on proprietary formulations that use patented technologies to enhance the efficacy and safety of natural and pharmaceutical ingredients that have proven health benefits. Vizuri wholly owns the patented CGS-200 and PainBloc24® products.
Vizuri Health Sciences LLC
William Moore, 443-961-8231