2020 was yet another quiet year for the fibromyalgia community. There were no major headlines, and yet thousands of researchers, physicians and advocates worked behind the scenes, inching toward better treatments, testing and quality of life for fibromyalgia patients.
Below is a summary of some of the most important fibromyalgia-related news stories from the past year. These small but mighty advances should lead to even more progress during 2021.
New fibro drugs are in the pipeline
In September, biopharmaceutical company Aptinyx, Inc. resumed patient recruitment for a phase 2 study of NYX-2925, a novel N-methyl-D-aspartate receptor modulator, after temporarily halting the trial in March due to the COVID-19 pandemic.
Aptinyx expects to release results from the trial during the first half of 2022.
Astellas Pharma Global Development, Inc. published efficacy and safety results from a phase 2a “proof of concept” trial of ASP0819, a novel, non-opioid pharmaceutical, which uses a calcium-activated potassium channel to reduce fibromyalgia-related nerve pain. While ASP0819 did not meet the primary goal of improving patients’ daily average pain scores at eight weeks, it did show promise at weeks two, six and seven.
Astellas did not respond to an email asking about future fibromyalgia-related trials of ASP0819.
Axsome Therapeutics, Inc. obtained exclusive rights from Pfizer to develop and market esreboxetine (aka AXS-14) as a potential treatment for fibromyalgia. Esreboxetine has been proven effective at reducing fibromyalgia pain during prior phase 2 and phase 3 trials.
Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, announced TNX-102 SL, a sublingual version of the common muscle relaxer cyclobenzaprine, met its primary goal of relieving pain during a randomized, double-blind, placebo-controlled trial.
TNX-102 SL targets the disturbed sleep of fibromyalgia patients, which in turn may lead to reductions in pain, fatigue and other symptoms.
Tonix is currently recruiting for a second 14-week trial of TNX-102 SL. If the results of that trial are positive, the company plans to submit a new drug application to the U.S. Food and Drug Administration (FDA) next year seeking approval for TNX-102 SL as a fibromyalgia treatment.
If successful, TNX-102 SL would become the first drug approved by the FDA for fibromyalgia in more than a decade.
Virios Therapeutics (formerly known as Innovative Med Concepts) filed to raise $34.5 million in an initial public offering of stock. The funding will be used to test the effectiveness of IMC-1, a potential fibromyalgia drug candidate that combines famciclovir, a common antiviral medication, with celecoxib, an anti-inflammatory arthritis drug with antiviral properties.
Dr. William L. Pridgen, a general surgeon based in Tuscaloosa, Alabama, discovered the drug combo while treating fibromyalgia patients for gastrointestinal issues. He theorizes fibromyalgia is caused by HSV-1, the common herpes virus that causes cold sores.
A phase 2 trial of IMC-1 is expected to commence sometime this year.
Opioid supply temporarily rebounds
After years of cutting the nation’s opioid supply, the Drug Enforcement Administration (DEA) reversed course last April after hospital staff complained they were running out of fentanyl, morphine and hydromorphone, which are used by COVID-19 patients on ventilators.
The temporary increase in production was short-lived. Last September, the DEA proposed reducing 2021’s hydrocodone production by 9%, oxycodone by 13%, hydromorphone by almost 20% and fentanyl by 29%. The cuts were suggested after the FDA predicted demand for opioids will fall this year.
Evidence lacking for most fibromyalgia treatments
A systematic review carried out by Brazilian and Australian researchers found very few fibromyalgia treatments are effective at relieving pain or improving quality of life.
“Strong evidence supported only cognitive behavioral therapy for pain, as well as antidepressants and central nervous system depressants for pain and quality of life, but these associations were small,” read a summary of the review. “This systematic review and meta-analysis suggests that most of the currently available therapies for the management of fibromyalgia are not supported by high-quality evidence. Some therapies may reduce pain and improve [quality of life] in the short to medium term, although the effect size of the associations might not be clinically important to patients.”
Association redefines pain
For the first time in more than 40 years, the International Association for the Study of Pain (IASP) updated its definition of pain. The revised definition now reads, “An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.”
Some IASP members had requested the change to incorporate research-driven advances in the understanding of pain and its management. The new definition will be used by the medical community as well as professional, governmental and other organizations such as the World Health Organization.
Cannabis research expands
- Most fibromyalgia patients from a small Brazilian study reported improvements in pain and fatigue levels, their ability to work and overall wellbeing after using THC-rich cannabis oil for eight weeks.
- An Italian study showed fibromyalgia patients’ sleep, functionality and symptoms improved after using THC-rich and balanced THC/CBD cannabis oils for six months.
- A systematic review from the University of Arizona suggested non-cancer chronic pain patients may be more likely to reduce their use of opioids when used in combination with medical cannabis. However, researchers cautioned “more research is needed to elucidate whether [medical cannabis] used in combination with opioids in the treatment of non-cancer chronic pain is associated with health consequences that are yet unknown.”
- The United Nations’ Commission on Narcotic Drugs (CND) removed cannabis from the 1961 Single Convention on Narcotic Drugs as a schedule IV drug. The vote “opened the door to recognizing the medicinal and therapeutic potential of the drug, although its use for non-medical and non-scientific purposes will continue to remain illegal,” reads a UN press release.
Fallout from opioid prescribing guideline continues
In a 17-page letter, the American Medical Association asked the Centers for Disease Control and Prevention (CDC) to amend the CDC’s Guideline for Prescribing Opioids for Chronic Pain because it has “harmed patients.”
The CDC adopted the guideline in 2016, leading to thousands of chronic pain patients losing access to prescription opioids and physicians being scared to prescribe them.
“The CDC guideline could be substantially improved in three overarching ways,” read the letter. “First, by incorporating some fundamental revisions that acknowledge that many patients experience pain that is not well controlled, substantially impairs their quality of life and/or functional status, stigmatizes them and could be managed with more compassionate patient care. Second, by using the revised CDC guideline as part of a coordinated federal strategy to help ensure patients with pain receive comprehensive care delivered in a patient-centric approach. And third, by urging state legislatures, payers, pharmacy chains, pharmacy benefit management companies and all other stakeholders to immediately suspend use of the CDC guideline as an arbitrary policy to limit, discontinue or taper a patient’s opioid therapy.”
Last July, the CDC tapped physicians, researchers and patients to a new workgroup, which will help the agency update and possibly expand the opioid prescribing guideline later this year.
There’s finally something good about having fibromyalgia
During past research, EpicGenetics CEO Dr. Bruce Gillis found those with fibromyalgia have a malfunctioning immune system that makes fewer IL-6 and IL-8 cytokines. Those two cytokines just happen to be the same ones that trigger the worst COVID-19 symptoms.
Last year, EpicGenetics polled thousands of patients who tested positive for fibromyalgia using the FM/a test and found that none of them had been hospitalized for COVID-19 or died from it.
Fibromyalgia tests move forward
Autoimmune testing laboratory Exagen, Inc. and the Ohio State Innovation Foundation are partnering to develop “a novel blood test using vibrational spectroscopy and metabolomic analysis to differentiate patients with fibromyalgia from rheumatoid arthritis, osteoarthritis, chronic lower back pain and systemic lupus erythematosus.”
In other testing news, EpicGenetics, the developer of the FM/a fibromyalgia blood test, has contracted with the Mayo Clinic’s Fibromyalgia and Chronic Fatigue Clinic to investigate whether the test can objectively diagnose fibromyalgia.
The FM/a test has been available to patients since 2012 but most fibromyalgia doctors and rheumatological associations do not accept it as a valid test.
Now it’s your turn: What headlines from 2020 were you most excited by? Share in the comments!
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