January 22, 2020 FAIRFAX, VA.–(BUSINESS WIRE)– Vizuri Health Sciences LLC, a pharmaceutical development company which pioneers the development of non-opioid pain management products, reports that the American College of Rheumatology (ACR), an organization of physicians and health professionals that advances education, research, advocacy and practice support for the care of people with arthritis, has announced updated 2019 treatment guidelines for the management of OA of the hand, hip, and knee.
The ACR, in collaboration with the Arthritis Foundation, published the revisions to its 2012 treatment guidelines for the management of OA (ACR-Arthritis Foundation Treatment Guidelines for Osteoarthritis | RheumNow – Rheumatology News & Information). The revisions were made based on information from randomized clinical trials that have become publicly available since ACR’s last review in 2012.
Key revisions to the 2019 OA Treatment Guidelines highlighted by ACR include:
- A conditional recommendation for the use of topical capsaicin in patients with OA of the knee (the 2012 guideline contained a conditional recommendation against topical capsaicin)
- Strong recommendations for self-efficacy/self-management programs
The full list of the 2019 recommendations and the supporting evidence for them is available at Clinical Practice Guidelines Osteoarthritis.
ACR released the 2019 Treatment Guidelines for OA following its November 2019 annual meeting, for which Vizuri had been selected to orally present results from its Phase 2 trial, VZU00025, a randomized, double-blind, clinical study of CGS-200-5 (5% topical capsaicin), CGS-200-1 (1% topical capsaicin), and CGS-200-0 (vehicle, no capsaicin) in subjects with knee pain due to OA.
Findings from the VZU00025 study reported at the ACR’s annual meeting included:
- CGS-200-5, following four once-daily applications to the knees (study Days 1-4), met the primary pain efficacy study endpoint, a Day 35 reduction in WOMAC Pain compared to vehicle (p = 0.020); a post-hoc analysis additionally showed a statistically significant reduction in WOMAC pain in the CGS-200-5 group compared to vehicle on Days 64 (p = 0.0001) and 94 (p = 0.0111), 2 and 3 months after treatment was completed.
- Post-hoc analysis also showed a statistically significant decrease in WOMAC Total Score (a composite index of knee pain, stiffness, and function) in the CGS-200-5 group compared to vehicle 30 days, 60 days, and 90 days after treatment was completed.
Vizuri has made detailed information from the VZU00025 study publicly available (Clinicaltrials.gov). CGS-200-5 is an experimental treatment that requires additional clinical testing before it can be approved by the Food and Drug Administration (FDA), and made available to patients by prescription only.
Vizuri currently markets a patented, over-the-counter (OTC), topical analgesic product, PainBloc24®, for OA pain sufferers who need relief now. PainBloc24® utilizes 0.25% capsaicin as the active ingredient in the same formulation as CGS-200-5. The 0.25% capsaicin concentration in PainBloc24® is the maximum strength allowed by the FDA in a topical OTC analgesic product. PainBloc24® is the only OTC external analgesic available in the US that utilizes 0.25% capsaicin. CGS-200-5 and PainBloc24® are jointly protected by three issued US patents and a fourth recently allowed patent.
PainBloc24®is commercially available in a roll-on dispenser ideal for larger areas of the body like the knees, and in a new Pain Pen applicator that allows precise topical delivery to smaller areas of the body. PainBloc24® is currently available to consumers at retail stores including Walgreens, CVS, Rite Aid, Meijer, Kroger and on-line through Amazon at http://bit.ly/PainBloc24 and at http://bit.ly/PainBloc24PainPen.
According to the Arthritis Foundation (Arthritis.org), arthritis is the nation’s leading cause of disability and OA is the most common form; 31 million US adults have OA and the incidence is increasing. Over time, people with knee OA tend to become inactive due to pain, joint stiffness and reduced function which puts them at risk for health conditions such as cardiovascular disease, diabetes, and obesity. The Arthritis Foundation’s Ease of Use Commendation recognizes products proven to make life easier for people who have arthritis.
PainBloc24® is a patented formula that is available without a prescription. It has been clinically shown that following use every day for a week, PainBloc24® can provide relief of knee OA pain that lasts for 24 hours a day all month long and that the pain relief builds with continued daily use. Like CGS-200, it helps to block OA pain at the source of the signal.
CGS-200-5 is a patented, topical analgesic that is wholly owned by Vizuri. It is being developed to address the high, unmet medical need for a prescription-strength OA pain treatment that is highly and durably effective, can be self-administered, does not require everyday use, and that is very safe (e.g., without the gastrointestinal, liver or addiction risk associated with other analgesics).
About Vizuri Health Sciences LLC (www.vizuriusa.com)
Privately-owned Vizuri develops new innovative healthcare products that utilize proprietary formulations or delivery techniques to enhance the efficacy or safety of pharmaceutical ingredients that have proven health benefits.
William Moore, CEO