Clarity Science, a division of Safe Harbor Compliance and Clinical Services LLC, report results of the Institutional Review Board (IRB)- approved Optimizing Patient Experience and Response to Topical Analgesics (OPERA) Study which evaluated patients with chronic pain who were treated with topical analgesics. Overall results, published today in the Journal of Pain Research, suggest that topical treatments may provide an effective and safer treatment alternative to opioids and prescription NSAIDs for the management of chronic pain.
Chronic pain is a leading cause of disability in the United States. It affects over 100 million Americans and is one of the most frequent reasons people seek medical care. Despite a wealth of treatment options, as many as 40% of patients treated for chronic pain do not attain adequate relief.
Further compounding this problem, patients who report chronic pain often suffer from multiple conditions and take multiple medications such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) that are associated with adverse effects including abuse, addiction, and death.
The FDA and CDC have recognized that opioid misuse and overdose have reached epidemic proportions. The number of prescriptions for opioids and other controlled substances increased dramatically in recent years and deaths associated with opioids continue to grow. Recent data from the National Center for Health Statistics reports over 64,000 drug overdose deaths in 2016 -- a faster rate than the HIV epidemic, car crashes, and gun deaths at their respective peaks.
According to Jeffrey Gudin, the lead investigator of the study and the Director of Pain and Palliative Care at Englewood Hospital in New Jersey, "The results of this study show that topical analgesics were associated with reductions of up to 60% in the use of concurrent pain medications, including oral opioid analgesics. Topical agents have the potential to provide analgesic effects without the risk of abuse, misuse, and addiction or systemic adverse events (AEs) associated with oral analgesics. Also, they lower the risk of systemic AEs and drug-drug interactions, have limited systemic absorption, offer simple-dose determination, provide direct access to the target site, and are easy for patients to apply."
Results of the Study show that topical treatments are effective and safe for the relief of moderately severe chronic pain associated with arthritis, neuropathic conditions, and musculoskeletal disorders while not carrying the same risks of abuse, misuse, addiction or adverse effects associated with some oral treatments. 54% of treated patients in the 3-month group and 60% of treated patients in the 6-month group de-escalated the use of concurrent pain medications compared to 4% and 6% in the untreated groups. The untreated groups saw an increase in medication usage in 52% of cases (compared to only 10% for the treated group.)
Treated patients reported a preference for topical treatments both for their convenience and ease of use and 99.5% of patients reported no side effects while using the topical treatments.
Dennis Harris, MD, Clarity's Chief Medical Officer and an author of the study notes, "The study is important in that existing topical analgesics that have lost big Pharma interest have been found not only to have a profound therapeutic effect, but also offer a safe and effective alternative to opioids. The study demonstrates a measurable improvement in quality of life. New and experimental drugs are not always the answer to current issues; even with generic combinations, we can immediately address such monumental issues such as the current opioid epidemic."