Daily & Localized NSAID Sonophoresis for Symptomatic Treatment of Knee Osteoarthritis

Project Summary: Arthritis is a significant economic and health burden in the United States which is estimated to exceed $394 billion in healthcare costs by 2030. Osteoarthritis (OA) is the most common type of arthritis, affecting over 32 million adults in the United States and represents over 25% of medical office visits according to the Centers for

Disease Control and Prevention and the National Institutes of Health. Over 40% of individuals over 65 have symptomatic OA and reduced mobility due to the disease. OA pain is often mitigated with conservative treatment approaches such as water therapy, walking, cycling, and pharmaceuticals. Regular use of NSAIDs can have

adverse side effects on cardiovascular, gastrointestinal and renal systems. As such, topical NSAIDs and intra- articular corticosteroids are often used to provide localized pain relief for patients. However, neither of these therapeutic approaches provide pain relief without risks including skin irritation, infection and accelerated loss of

cartilage. Long-duration ultrasound has been used to reduce pain and improve joint function in patients with knee OA. When ultrasound is used in conjunction with topical pharmaceuticals, sonophoresis drives the molecules deeper into tissue, providing improved pain relief compared to ultrasound or topical application of NSAIDs alone.

In our SBIR Phase I/II project, we developed a novel diclofenac sonophoresis patch for the management of knee OA. We demonstrated that the sonophoresis technology could increase tissue penetration of NSAIDs by 3.8x compared to standard of care (p