PainRelief.com Interview with: Michael Verret MD FRCPC Alexis F. Turgeon MD MSc FRCPC Laval University, Québec
PainRelief.com: What is the background for this study? What are the main findings?
Response: Gabapentinoids is a class of drugs including gabapentin and pregabalin that is frequently used for the management of postoperative pain as a part of multimodal analgesia regimen. This off-label use of gabapentinoids is increasing in many countries despite an unclear level of evidence and off-label use.
In our meta-analysis of 281 randomized controlled trials, the perioperative use of gabapentinoids was not associated with clinically significant difference in postoperative acute, subacute or chronic pain intensity compared to control. These findings were consistent regardless of the type of drug (gabapentin or pregabalin) and the dosage regimen. Gabapentinoids were also associated with an increased risk of adverse events such as dizziness and visual disturbance.
PainRelief.com Interview with: Sandip Biswal MD Associate Professor of Radiology Co-Section Chief, Musculoskeletal Imaging Director, Musculoskeletal Imaging Fellowship Member, Molecular Imaging Program at Stanford (MIPS) and Bio-X Department of Radiology Stanford University School of Medicine
PainRelief.com: What is the background for this study? Response: Our ability to manage patients with chronic pain remains woefully inadequate. Chronic pain patients are faced with limited resources and inadequate care, and as a result, they make up the #1 disease group in the world—numbering more than heart disease, diabetes and cancer combined. Those suffering from low back pain, headache, fibromyalgia, arthritis and many other pain syndromes make up this ever-growing population. A big part of our inability to care for chronic pain patients is due to the fact that our current imaging methods for correctly identifying pain generators remain substantially inaccurate. Our ability to accurately identify the cause of a person’s pain, discomfort, inflammation or other related musculoskeletal symptom(s) using current clinical imaging approaches, such as magnetic resonance imaging (MRI), computed tomography (CT), digital radiography (x-ray) and ultrasound, is quite limited, lacks sensitivity/specificity and can even misguide treatment. As a musculoskeletal radiologist, I witness these shortcomings on a daily basis. I, for example, see firsthand how the lack of reliable diagnostic tools leads to significant misdiagnosis, mismanagement, incorrect use of opioids, unhelpful surgeries and, ultimately, therapeutic failures. We need a much better way to diagnose pain generators.
Accordingly, our group has been developing new clinical imaging methods that pinpoint the site of pain generation using imaging probes—more specifically, positron-emission tomography (PET) tracers that specifically target “pain receptors” or “pain molecules.” These pain receptors or pain molecules are present in abundance at the site of pain generation. After injecting one of these imaging probes into a patient through the vein, we give the probe a few minutes to circulate around the body and stick to areas that have a high density of pain receptors. We can then take a picture of the patient with a special camera that will show “hot spots” on the image that signify the location of high number of pain receptors, thereby highlighting “painful” pro-inflammatory and/or pro-nociceptive tissues. With this approach, doctors and patients have information with which they can make more objective decisions about the diagnosis and treatment of one’s pain.
PainRelief.com Interview with: Rahul Shah Medical Student The University of Texas Medical Branch
PainRelief.com: What is the background for this study?
Response: The United States has a unique overreliance on opioids for managing both acute and chronic pain, compared to many other developed nations. Opioid misuse and addiction frequently start with large doses of opioids prescribed after surgical interventions. This overprescribing contributes to the high rates of opioid use disorder and overdose deaths in the United States. There have been myriad interventions to curb opioid overprescribing, ranging from the DEA’s hydrocodone rescheduling law to opioid prescribing guidelines issued by the CDC, states and orthopedics specialty organizations.
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.
“Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.” Link
“Tanezumab 2.5 mg administered subcutaneously (SC), which is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis (OA) who have experienced inadequate pain relief with other analgesics.” Link
Comments from Pfizer regarding the study of Tanezumab for chronic low back pain, July 21 2020.
“Pfizer and Lilly made the decision to prioritize tanezumab as a potential treatment for osteoarthritis, based on an assessment of the totality of SC tanezumab data and an initial discussion with the FDA.
At this time, regulatory submissions are not planned for tanezumab in patients with moderate-to-severe chronic low back pain (CLBP), but we recognize the significant patient needs and intend to maintain an open dialogue with regulatory authorities on potential future regulatory pathways for tanezumab. Additional data analyses, and potentially further clinical study, may be required to more fully characterize tanezumab in CLBP patients.“
PainRelief.com Interview with: ROSS ILES PhD, Dip WDP, BPhysio(Hons) Insurance Work and Health Group Senior Research Fellow Department of Physiotherapy Adjunct Senior Lecturer,Health Services Division School of Public Health and Preventive Medicine Monash University Melbourne, VIC Australia
Dr. ILES
PainRelief.com: What is the background for this study
Response: Chronic neck pain is estimated to have a worldwide mean lifetime prevalence of 48.5%, and the pain and disability associated with this condition accounts for 2.5% of the total years lost to disability in Australia. Chronic neck pain is known to be associated with neck muscle weakness in all planes of movement of up to 66% when compared to participants presenting with no history of neck pain. Therefore, neck strengthening exercises are commonly utilised in the treatment of chronic neck pain, with many different programs being described within the literature. Studies investigating the effect of strengthening exercises on chronic neck pain have found a short to intermediate term improvement in pain by a moderate to large amount. However, many strengthening programs do not target the multi-directional weakness which has been shown to be prevalent in this population group.
Through a case series of patients with chronic neck pain we aimed to determine whether a neck-specific progressive resistance program targeting all planes of cervical movement led to a change in pain and disability, and to investigate the relationship between neck strength, pain, and disability.
Data analysis was performed on patients after completing nine sessions of a neck-specific progressive resistance exercise intervention utilising the Melbourne Protocol and the Multi-Cervical Unit (MCU) technology under supervision of the treating physiotherapist. Participants completed isotonic exercises against the MCU provided resistance in the planes of cervical flexion, extension, and lateral flexion, all at neutral cervical rotation and 25 degrees left and right. Neck pain and disability were assessed with the Numerical Rating Scale (NRS) and Neck Disability Index (NDI) respectively, with neck strength measured and recorded through the MCU.
Johan Hambraeus, MD Board certified in anesthesiology, family medicine & Pain management Department of Epidemiology and Global Health Umeå University, Sweden
PainRelief.com: What is the background for this study?
Response: When working with interventional pain management a striking feature is that all procedures are painful. It is often discussed about sedation before procedures, but whether to provide sedation seems to be more based on the local tradition than on facts. And it is not seldom that patients describe that they have phobic fear of needles, but despite this they cope with the interventional pain management and all the painful procedures.
Therefore we wanted to understand how it is felt and how the patients describe their experiences.
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