The use of Opioids and Rx NSAIDs to treat pain is increasing
Americans endure more pain than any country1 in the world, not to mention the 50 million Americans2 that endure chronic pain. In response, Americans have consistently reached for pills as their first line therapy for managing pain. This first choice is not the way it is in other parts of the world and using pain pills exclusively may be adding to concerns around oral Opioids and NSAIDS (e.g. Diclofenac, Ibuprofen, Naproxen Sodium or the analgesic acetaminophen), both of which have benefit but also come with significant risks, especially if used beyond the label. For all OTC pain medications, topical or internal, it is important to read and follow label directions and warnings, including consulting a physician. Pain which is prolonged, or recurring may indicate an underlying disease or disorder which can progress if not evaluated and treated.
Hisamitsu America, marketers of Salonpas have a global perspective on pain management where in many countries, Topical Analgesics are a first line therapy. Learn more below on the clinical science and how even one of the USA’s top health authorities, the Center for Disease Control (CDC), are encouraging consumers, physicians and pharmacists to consider broader use of Topicals First.
These options can be harmful and the evidence is mounting outlining their potential danger
Oral pain relievers, mainly opioids and NSAIDs, are leading causes of Serious Adverse Events (SAE’s).
- Since 2000, over 200,000 people in the USA have died from overdose of prescription opioids3
- Between 3,200 and 16,500 deaths a year are attributed to NSAIDs for GI Bleed & CV risks4
- Once weekly NSAID use occurs in an estimated 70% of 65 and older population, and is a leading cause of hospitalization in this age cohort. Preventable hospital admissions in this group was found to be as high as 11%.5
- In the U.K., oral NSAIDs are responsible for 30% of hospitalizations due to adverse drug reactions. The U.K.’s National Institute for Health and Care Excellence (NICE) issued guidelines to use topical analgesics as a first-line treatment in managing pain in older patients.6
Topicals are a safe and effective alternative pain management
The United States Center for Disease Control (CDC) issued guidance and training modules on prescribing opioids for chronic pain. In Module 2, “Treating Chronic Pain with Opioids”, the CDC clearly suggests Topical Analgesics should be considered a first-line treatment for pain.7
- Can use topicals as an alternative first-line treatment
- Examples: Lidocaine, Capsaicin, Topical NSAIDs
- Can be safer than Systemic Medications
Clinical research is demonstrating that topical analgesics are effective and safe.
- In July 2017, the Journal of Pain Management published a comparison of transdermal OTC Lidocaine 3.6% and Menthol 1.25% with Rx Lidocaine 5% and placebo for back pain and arthritis8
- The study demonstrated that there was no difference in levels of pain relief safety and quality of life between the OTC product and the 5% Rx Lidocaine patch (As Lidoderm-peak yr. Rx Sales = $1.3 billion USA at AWP)
In January 2010, Clinical Therapeutics published a study from Hisamitsu Pharmaceutical Co., “Efficacy and safety profile of a topical methyl salicylate and menthol patch in adult patients with mild to moderate muscle strain: A randomized, double-blind, parallel-group, placebo-controlled, multicenter study.” This was the pivotal study in the company’s filing of an NDA for Salonpas Pain Relief Patch, which was approved in 2008 by FDA as the first and only Topical NSAID.9
The study confirmed the efficacy of the patch versus placebo and yielded the product a unique label indication—Salonpas Pain Relief Patch is the only OTC pain medicine approved to treat mild and moderate pain; something no OTC Systemic Analgesic can claim.
In October 2017, the Journal of Pain Research published a study: “Changes in pain and concurrent pain medication use following compounded topical analgesic treatment for chronic pain: 3- and 6-month follow-up results from the prospective, observational Optimizing Patient Experience and Response to Topical Analgesics study” (OPERA)10
- Eye-opening, preliminary study employed compounded topical (Flurbiprofen, Diclofenac Ketoprofen) NSAID creams interventionally on moderate to severe pain sufferers of arthritic, musculoskeletal, or neuralgic pain
- Patients were all being treated with Rx oral NSAIDS, opioids or both at start of intervention with compounded topical agents
- The study concluded, although preliminary, that topical NSAIDS appear to be safe and effective to treat chronic pain. More importantly, the study showed a de-escalation of oral Rx NSAID and opioid use of:
- 53.6% in the unmatched intervention Group
- 52.1% in the matched intervention Group
- Over 50% of opioid users were off opioids at the 6 month mark
Around the world, people turn to topicals as an effective and safer pain relief option
The overwhelming majority of consumers, pharmacists, and physicians in the USA continue to eschew use of topical pain relievers out of lack of awareness, efficacy skepticism, or both.
- With the exception of Canada and the USA, Topical Analgesics are more widely recommended, prescribed, and consumed in other countries11
- In some countries in Asia, topical analgesics are used more than systemic analgesics12
Salonpas® Pain Relief Patch LARGE efficacy has been clinically demonstrated, and it remains:
- The first and only FDA approved topical NSAID
- The only OTC pain reliever labeled to treat mild and moderate pain
- The strongest labeled pain reliever you can buy without a prescription
We believe the fulfillment of our mission is nothing less than an obligation to the global community. It is with that in mind that we work to improve our products and promote new means for people everywhere to apply the many benefits of topical care. Hisamitsu’s goal has always been to advance the benefits of topical analgesics treatments, especially their pain-relieving effects and the feeling of invigoration they offer. Nowhere is this objective better expressed than in our corporate maxim, “Salonpathy”. This word was derived from SALONPAS®, one of our key products. Under the banner of Salonpathy, we are actively promoting better health for people around the world, offering a range of pain relieving patches and pharmaceutical products. As the 21st century begins, we are responding to basic needs that unite people everywhere. Good health, freedom from pain and a lifestyle rich in vitality, is the foundation for all we do at Hisamitsu. Our business strategy is designed to develop new medical products and drugs commensurate with our core competencies in topical analgesics. This is our mission, to make topical care available for all who seek it—anytime, anywhere.
Contact Us if you have any questions.
- Khazan, Olga, “America Experiences More Pain Than Other Countries,” The Atlantic, released December 2017.
- Center for Disease Control and Prevention, Morbidity and Mortality Weekly Report, “Prevalence of Chronic Pain and High-Impact Chronic Pain”
- Center for Disease Control and Prevention, National Center for Health Statistics. “Multiple Cause of Death 1999-2017” on CDC WONDER Online Database, released December, 2018
- Tarore RE, Blot WJ, McLaughlin JK, “Nonselective non aspirin, non-steroidal anti-inflammatory Drugs and gastrointestinal bleeding relative and absolute risk from epidemiological studies.” American Journal of Therapeutics 2004;11(1) 17-25
- John Hawboldt, BSP, ACPR, PharmD, Assistant Professor, School of Pharmacy Memorial University of Newfoundland/St. John’s, Newfoundland and Babrador. US Pharmacist,2008;33(12): JS5-HS13
- British Journal of General Practice, April 2016
- Deborah Dowell, MD, Tamara M. Haegerich, PhD, Roger Chou, MD. Centers for Disease Control and Prevention (CDC) March 18, 2016/65(1) 1-49
- Eric Castro & David Dent, “A comparison of transdermal over-the counter lidocaine 3.6% menthol 1.25%, Rx lidocaine 5% and placebo for back and arthritis,” Future Medicine Ltd. 10.2217/pmt-2017-0029
- Yoshinobu Higashi, MS, Takehito Kiuchi, MS, and Kenichi Furuta, BS, Clinical Therapeutics, The International Peer-Reviewed Journal of Drug Therapy, Volume 32, Number 1, January 2010.
- “Changes in pain and concurrent pain medication use following compounded topical analgesic treatment for chronic pain: 3- and 6- month follow-up results from the prospective, observational Optimizing Patient Experience and Response to Topical Analgesics study,” Journal of Pain Research 2017: 10 2341-2354.
- Data on file Hisamitsu America Inc.
- Data on file Hisamitsu America Inc.