The comprehensive Institutional Review Board (IRB)-approved study evaluated whether a topical analgesic pain-relieving patch containing methyl salicylate (10%), Menthol (6%) and Camphor (3.1%) could reduce pain severity and improve function in patients with mild-to-moderate arthritic, neurological or musculoskeletal pain as compared to oral over-the-counter (OTC) agents (e.g., ibuprofen, naproxen, acetaminophen, and other pain medications such as creams, gels, roll-ons, sprays, patches or rubs, prescription NSAIDs (e.g., ibuprofen, naproxen, celecoxib, meloxicam or diclofenac), prescription opioids (e.g., fentanyl, hydrocodone, hydromorphone, morphine or oxycodone), or prescription anticonvulsants (e.g., gabapentin or pregabalin).
The treatment group for the RELIEF study included 152 adult patients with arthritis, neurological, or musculoskeletal pain who received the Salonpas Pain Relieving Patch for 14 days. A control group included 47 patients who did not receive the patch – 34 of whom crossed over to evaluate their response to patch treatment as well.
Pain severity in treated patients decreased significantly, by 49.0% compared to 12.3% in patients in the control group, while function significantly improved by 58.1% compared to 14.8% in patients in the control group. Additionally, no side effects of treatment were reported. Also, at day 14, 60.5% of the treated patients were using concomitant oral pain medications a lot less and 90.8% of patients were very or extremely satisfied with the patch. Patients in the crossover group showed similar reductions in pain severity and improvement in function.
“Clinical treatment guidelines increasingly recommend the first-line use of topical analgesics, largely based on safety concerns associated with oral medications such as oral NSAIDs, acetaminophen, opioids, and anticonvulsants, which require substantial systemic exposure in order to have their therapeutic effect and pose associated risk of serious adverse events,” said Dr. Jeffrey Gudin, the principal investigator of the RELIEF study who is board certified in pain management, anesthesiology, addiction medicine and palliative care. Dr. Gudin is affiliated with Englewood Hospital Medical Center and Rutgers New Jersey Medical School, Dept. of Anesthesiology, and is an author, researcher and opinion leader in pain management. “The RELIEF study not only supported the safety of this multimodal topical analgesic (Salonpas Pain Relieving Patch), it also supported the treatment’s significant pain relieving effect in patients with mild to moderate pain, its favorable impact on function, and illustrated that its use reduced the use of oral NSAIDs, acetaminophen, opioids, and anticonvulsants.”
“Our mission is to provide people in pain with clinically proven topical analgesics and practitioners with the clinical proof they need to confidently recommend our products for their patients,” said John Incledon, the president of Hisamitsu America Inc. “Prior to the RELIEF study, Hisamitsu supported the clinical evaluation of another one of it products, the Salonpas Pain Relief Patch LARGE. The study was a well-controlled clinical study involving 208 patients with mild to moderate pain. Patients treated with the product experienced significantly more pain relief versus patients treated with a placebo patch and the majority of patients rated satisfaction with the product as good, very good, or excellent. This study ultimately supported an FDA approval of a New Drug Application for the product, making it not only the first FDA approved OTC topical analgesic, but also the only OTC pain reliever, systemic or topical, that is approved to treat mild and moderate pain. We will continue to provide people in pain and health care practitioners with clinical proof of the efficacy and safety of our products, so stay tuned for more news to come.”
Oral pain relievers, mainly opioids, NSAIDs and acetaminophen are leading causes of serious adverse events (SAE’s); addiction, hospitalization for CV & GI risk, liver toxicity, and death. The Center for Disease Control (CDC) reports that since 2000, over 200,000 people in the USA have died from overdose of prescription opioids. In 2016, the CDC issued guidance to physicians managing chronic pain without opioids, that topical analgesics can be an alternative first line therapy.
Based in Narragansett, Rhode Island, Clarity Science conducts scientifically rigorous and valid research that advances innovation in science and ultimately helps healthcare professionals provide improved patient care, leading to improved patient health worldwide.
Hisamitsu America provided a grant to Clarity Science to administer and conduct the IRB-approved study to collect data on patient outcomes for Quality of Life (QoL) components, pain relief scores and assessment of severity of pain and its impact on functioning, patient satisfaction, and an evaluation of differences, reported medical conditions and other prescribed or OTC oral medications commonly associated with pain.