Kelechi R. Okoroha, M.D. Division of Sports Medicine Department of Orthopedic Surgery Henry Ford Health System
Dr. Okoroha
PainRelief.com: What is the background for this study?
Response: The United States is in the midst of an opioid epidemic. Postoperative prescriptions following surgery is thought to have a direct role in the availability and exposure of opioids to the general population. This study was created in order to assess the viability of having common sports surgeries without the use of opioids.
PainRelief.com: What are the main findings?
Response: Our studies main findings were that common sports procedures can be performed with little or no opioids. 45% of patients did not require breakthrough opioid medication and all patients were satisfied with their pain management. Factors that were associated with requiring opioids included history of anxiety/depression.
PainRelief.com Interview with: Brian Cheng, PharmD Senior Manager, Medical Affairs Galt Pharmaceuticals
PainRelief.com: What is the background for this announcement
Response: Galt Pharmaceuticals announced a new drug approval to offer a non-opioid, non-controlled, non-addictive alternative for healthcare providers to manage patients suffering from pain. On July 8, 2020, the U.S. Food and Drug Administration approved the company’s Supplemental Abbreviated New Drug Application for Orphengesic Forte (Orphenadrine Citrate, Aspirin, Caffeine tablets 50mg/770mg/60mg), over two months ahead of the scheduled goal date.
Orphengesic Forte is indicated for the relief of mild to moderate pain of acute musculoskeletal disorders, paired with rest, physical therapy and other measures. (More Important Safety Information is below.)
PainRelief.com Interview with: Hernan Bazan, MD DFSVS FACS CEO & Co-founder, South Rampart Pharma, LLC and Professor of Surgery, Section of Vascular/Endovascular Surgery Program Director, Vascular Surgery Fellowship Ochsner Clinic New Orleans, LA 70121
Thank you for your kind invitation and opportunity to commend on our paper in press in the European Journal of Medicinal Chemistry entitled ‘A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.’ This is the culmination of a multi-disciplinary effort involving investigators from the United States in Spain in search for a solution to the problem of treating pain more safely.
As a disclosure, I am the CEO and co-founder of South Rampart Pharma, LLC (https://southrampartpharma.com), which is developing its lead asset to advance the treatment of pain by developing new, small-molecule solutions that have the potential to overcome many risks associated with current pain medicines.
Dr. Hernan Bazan
PainRelief.com: What is the background for this study?
Response: The work in this paper is in large part due to several active and productive collaborations to address a simple problem: introduce a safer way to treat pain. That is, without the risk of opioids (abuse potential), acetaminophen/paracetamol (liver toxicity) and non-steroidal anti-inflammatory drugs (NSAIDs)/ibuprofen (kidney toxicity).
In 2018, over two million U.S. adults had opioid use disorder (OUD), which includes the misuse of prescription pain relievers and use of heroin (1). Prescription pain reliever misuse was the second most common form of illicit drug use in the U.S. in 2018, after marijuana use, with 3.6% of the population misusing pain relievers(1). In the U.S., pain affects more adults than diabetes and cancer combined with an estimated cost to the healthcare system of $635 billion/year(2). Current pain medications are either addictive (e.g., opioids), hepatotoxic (e.g., ApAP) or nephrotoxic (e.g., NSAIDs). For example, Paracetamol (or acetaminophen) (ApAP) is effective for acute pain but its hepatotoxicity risk limits its use to a short time period (usually < 3 days) and also its use in patients with compromised liver function or the elderly. The prevalence of OUD, including high rates of overdose in the U.S., OUD costs and toxicity profiles of currently available medications underscore the need for a safer, effective non-opioid pain medication.
ApAP-hepatotoxicity remains the most common cause of acute liver failure in the U.S. with inadvertent hepatotoxicity the etiology in half of all cases(3). Our aim was to overcome this toxicity by creating ApAP analogs linking a saccharin moiety to the methyl group of ApAP. To this, an efficient synthesis was possible through opening the ring of the heterocyclic moiety to supply the corresponding N-substituted amides(4, 5). Within this molecule, the benzenesulfonamide fragment makes the molecule stable and moderately lipophilic and the R1 and R2 groups can be varied to effect lipophilicity (Fig).
Figure. Fragments encompassing the novel non-narcotic, 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesic.
This paper describes the rationale for this synthesis, the library of compounds used to select the lead compounds to develop, the consistent lack of hepatotoxicity cell lines and small animals, and its ability to reduce pain and fever in small animal studies. Moreover, we explain the mechanisms of action for the lack of hepatotoxicity.
PainRelief.com Interview with: CarrieCuttler, Ph.D. Assistant ProfessorWashington State University Department of Psychology Pullman, WA, 99164-4820
PainRelief.com: What is the background for this study?
Response: Many people report using cannabis for headache and migraine and claim that it is effective in reducing their symptoms. However, to date there has only been one clinical trial examining the effectiveness of a cannabinoid drug called Nabilone (synthetic THC that is orally administered) on headache. The results of that trial indicated that Nabilone was more effective than ibuprofen in reducing pain and increasing quality of life. There have also been a couple of preclinical (animal) studies suggesting that cannabinoids like THC may be beneficial in the treatment of migraine. But there are surprisingly few studies examining the effectiveness of cannabis, particularly whole plant cannabis rather than synthetic cannabinoids on headache and migraine.
Donald I. Abrams, MD Division of Hematology-Oncology Department of Medicine, Zuckerberg San Francisco General Hospital University of California, San Francisco
PainRelief.com: What is the background for this study? What are the main findings?
Response: A number of years ago, Kalpna Gupta, PhD, an investigator then at the University of Minnesota, came and told me about her mice with Hemoglobin SS who experienced pain that responded to laboratory cannabinoids. She was going to apply for a grant from the National Heart, Lung and Blood Institute to continue her studies and sought us out because of our prior clinical trials with cannabis and pain. Dr. Gupta wanted to include a pilot proof of principle human study in her application and asked if we could design one. As cannabidiol (CBD) was just becoming known at that time, we suggested to do a study in patients with sickle cell disease and pain looking at a delta-9-tetrahydrocannabinol (THC)-dominant strain of inhaled cannabis, a CBD-dominant strain, a balanced 1:1 strain and placebo. She said that we would only have funds to do a two-arm study, one of which needed to be placebo. As we had already shown that there was a trend for vaporized cannabis that was predominantly THC to add to the analgesic effect of sustained-release opioids in patients with chronic pain, we chose to investigate a 4.4% THC:4.9% CBD product obtained from the National Institute on Drug Abuse.
We designed a crossover trial so that each participant would spend two 5-day inpatient stays separated by at least a month in our Clinical Research Center at Zuckerberg San Francisco General Hospital. During one stay they would add vaporized cannabis to their stable ongoing analgesic regimen and during the other stay they would inhale placebo cannabis three times a day. We use the Volcano vaporizer device that heats the plant material and not an oil as has become popular in the recent “vaping” craze. Our target was to enroll 35 patients with sickle cell disease and chronic ongoing pain on an opioid-containing regimen. Our primary endpoint was change in pain as measured by way of a visual analog scale and the Brief Pain Inventory as well as safety.
PainRelief.com Interview with: Eric J. Roseen, DC, MSc Department of Family Medicine Boston University School of Medicine Department of Rehabilitation Science Massachusetts General Hospital Institute of Health Professions Boston, MA 02215
PainRelief.com: What is the background for this study? What are the main findings?
Response: The Back to Health Study is a noninferiority randomized controlled trial of yoga, physical therapy, and back pain education for chronic low back pain. Participants were recruited from a SafetyNet hospital (Boston Medical Center) and seven affiliated federally-qualified community health centers. Participants reflected the population served by this health system, they were predominately low-income and non-white.
The yoga intervention consisted of 12 group-based, weekly, 75-minute, hatha yoga classes incorporating poses, relaxation and meditation exercises, yoga breathing and yoga philosophy. Thirty minutes of daily home practice was encouraged and supported with at-home yoga supplies. The physical therapy intervention consisted of 15 one-on-one 60-minute appointments over 12 weeks. During each appointment, the physical therapist utilized the Treatment-Based Classification Method and supervised aerobic exercise, while providing written instructions and supplies to continue exercises at home. The self-care intervention consisted of reading from a copy of The Back Pain Handbook, a comprehensive resource describing evidence-based self-management strategies for chronic lower back pain including stretching, strengthening, and the role of psychological and social factors. Participants received check-in calls regarding the reading every three weeks.
The main findings from the trial published in Annals of Internal Medicine found that yoga was non-inferior to physical therapy in terms of pain and function outcomes.
In this study published in Pain Medicine, we wanted to dig deeper and understand the characteristics of patients who tended to do better no matter what treatment they received (i.e., predictors) and characteristics that modified the likelihood that they would improve with a particular treatment (i.e., treatment effect modifiers). This type of information is useful to patients and clinicians who are trying to decide which type of treatment may be best for a unique individual experiencing back pain.
Shelly Levy-Tzedek, PhD Head of the Cognition, Aging and Rehabilitation Lab Faculty of Health Sciences, Dept. of Physical Therapy & The Zlotowski Center for Neuroscience & ABC Robotics Initiative The Ben Gurion University of the Negev
Prof. Levy-Tzedek
PainRelief.com: What is the background for this study? What are the main findings?
Response:It is known that close, effective human touch can help alleviate pain. We set out to test whether touch interaction with a social robot can also reduce the sensation of pain. We found that it does: young, healthy people who touched the robot during the application of painful stimuli reported feeling less pain than when it was in the room with them (with no direct contact), or when it was not present at all. They also reported increased levels of happiness.
PainRelief.com Interview with: Markéta SAINT AROMAN, MD Medical Director in Pierre Fabre Group.
PainRelief.com: What is the background for this study? What are the main findings?
Response: Patients with inflammatory skin diseases frequently experience cutaneous pain as a symptom of their disease and may also experience burning and stinging sensations.
Signs and symptoms of inflammation are also experienced by patients who have undergone therapeutic and aesthetic skin resurfacing procedures (such as laser treatment, chemical peels and photodynamic therapy).
Diseases such as eczema (atopic dermatitis (AD), hand eczema) and psoriasis and dermatological procedures are all associated with disruption to the skin barrier which can expose cutaneous nerve endings, which are responsible for transmitting sensory information including itch and pain and increase sensitivity to environmental irritants. Heat sensations and oedema associated with inflammation also activate pain receptors. The impulse to scratch, which is a feature of AD and psoriasis and also occurs during the healing process following dermatological procedures, is a cause of cutaneous pain. At a molecular level, inflammation is characterized by the release of prostaglandins, cytokines, chemokines, proteases, neuropeptides, and growth factors, which are known to act directly on peripheral pain-sensing neurons.
The efficacy of the spray used in the study may be explained by the inclusion of two plant extracts demonstrated to have anti-inflammatory, immunomodulatory and antalgic activities. The oat plantlet extract contains immumomodulatory saponins and anti-inflammatory flavonoids which inhibit the production of inflammatory mediators and stimulate keratinocyte proliferation and skin barrier repair.
The extract of Uncaria tomentosa contains active compounds targeting peripheral pain sensation pathways.
PainRelief.com Interview with: Matthew Halpert, Ph.D., B.S Baylor College of Medicine
PainRelief.com: What is the background for this study?
Response: The background will actually encompass my disclosure. A little over a year ago, Medterra was one of a couple of CBD companies that approached me about conducting some small scale studies focused on CBD and its anti-inflammatory properties. It became very obvious, very quickly that some (most) companies were not interested in actual science or data, but rather just wanted to try and increase their CBD-fad based revenue by using my name and affiliations. Medterra proved to be very different and genuinely wanted legitimate data and science to support and direct products, innovations, stories etc. I always warned them that the ‘data will be the data’ and they agreed to live by that….even if the data wasn’t as supportive as they may have hoped. Being a true academic researcher, I found this to be more than acceptable and Medterra and Baylor College of Medicine entered into a Sponsored Research Agreement (SRA) in which Medterra provides product and money for research, and my lab performs the research and reports back the data.
PainRelief.com Interview with: Karin Westlund High, PhD Professor and Vice-Chair for Research Department of Anesthesiology & Critical Care Medicine University of New Mexico Health Sciences Center Albuquerque, NM 87106
PainRelief.com: What are the main findings?
Response: Nearly 1 in 5 Americans recently reported that their level of pain interferes with their daily lives. Treatment options for persons with chronic pain are not optimal, particularly opioid therapies found to exacerbate pain or become ineffective over time in patients and in animal studies. While some have turned to marijuana to relieve pain where it has been legalized, benefits of the pain relieving cannabinols are not suitable for many given the psychotropic effects of its tetrahydrocannabinol (THC) content.
The Hemp Farming Act in 2019 effectively began legal cultivation in some states of a variety of the Cannabis plant—conventionally referred to as ‘hemp’. The primary components of hemp are the pain relieving cannabidiol (CBD) chemicals, differing from the content in their federally illegal counterparts which contain levels over 0.3% of the psychoactive THC. In fact, it is reported that the content of CBD was bred down while THC bred up in marijuana seized in California between 2001-2008.
The information on PainRelief.com is provided for educational purposes only, and is in no way intended to diagnose, endorese, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website. None of the content on PainRelief.com is warranted by the editors or owners of PainRelief.com or Eminent Domains Inc.
Thank you for visiting PainRelief.com
Senior Editor, Marie Benz MD.
For more information, or for advertising options please email: [email protected] or [email protected]
