A Novel Nutraceutical Drug for OA Treatment
Abstract
Over 27 million Americans are currently diagnosed with osteoarthritis (OA). OA is our nation s leading cause of pain and disability. Neither a disease-modifying OA drug nor a non-surgical cure presently exists. Many of the pharmacological agents used for OA to temporarily relieve pain may cause severe adverse effects with prolonged use. Moreover, patients experiencing pain relief without a concurrent improvement in the disease itself may become less conscious about protecting their diseased joints (such as by avoiding overuse). This may exacerbate progression of their OA. Therefore, it is extremely important to have a drug that mitigates OA disease progression and relieves OA pain, with minimal, if any, adverse effects. This application is proposed to address the FY17 PRORP Focus Areas on Osteoarthritis regarding treatment strategies involving large animal studies to improve outcomes of osteoarthritis and/or post-traumatic osteoarthritis. We have developed a novel drug composed of compounds that the Food and Drug Administration (FDA) has designated "GRAS" (generally recognized as safe) and found that it mitigates OA pathology and relieves OA-related pain in a rat model of post-traumatic OA. These data provide a strong feasibility to determine the therapeutic efficacy of this drug in human OA. Therefore, the goal of the proposed study is to determine the efficacy of this drug in mitigating disease and relieving pain using a canine model of post-traumatic OA, a large animal model that can well replicate the pathology and symptoms of human OA. Successful completion of the proposed studies will provide critical evidence to the FDA for approval for human clinical trials. We expect clinical demonstration of this drug s efficacy will bring a new disease-modifying OA drug to the market, currently projected to be 2027. Medically linked retirement caused by musculoskeletal disorders such as OA increased nearly 10-fold among active military Service members in the period 2003 to 2009. Moreover, the rate of OA in military service members at age 20 to 24 is reported 26% higher than the general population. Combined with Veterans, the rate of OA in military populations is twice as high as that in non-military populations. The research and development of this potential drug, upon success, will provide an urgent treatment need for military personnel, Veterans with OA, and general OA patients, and social and economic benefits to their families and society.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1810764
Entities
People
- Hui Sun
Organizations
- Albert Einstein College of Medicine
- United States Army