The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. The sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.
With mask mandates lifted and social gatherings occurring once again, people may be forgiven for thinking the acute threat of COVID-19 is over. But the shadow remains heavy for some, particularly for those suffering from so-called long COVID.
Among these longer-term sufferers, the most common symptoms are chronic fatigue, multi-site pain and respiratory issues. To make matters worse, approximately 35% of long COVID patients are prescribed addictive opioids to ease their multi-site pain symptoms. And that number can increase to 50% for those who also suffer from insomnia.
Those numbers come from a retrospective observational study of an electronic health record database of 50,000 long COVID patients and are backed up by the U.S. Department of Labor, which says that 25% of patients prescribed opioids long-term will suffer from lifelong addiction.
One drug developer wants to change the dominance of opioids as a treatment for long COVID sufferers and instead provide a nonopioid centrally acting analgesic in sublingual tablet form for daily use to help treat the debilitating condition. There is currently no drug approved for the treatment of multi-site pain in long COVID patients.
Easing The Pain
Tonix Pharmaceuticals Holding Corp. TNXP recently announced it has begun a Phase 2 trial of its drug TNX-102 SL for a subset of patients with long COVID symptoms that overlap with the symptoms of fibromyalgia, a chronic disorder featuring musculoskeletal pain and fatigue. Fibromyalgia is considered one of several overlapping chronic pain syndromes that includes myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), which are believed to be post-viral illnesses. The same Tonix drug is also in a Phase 3 trial for potentially treating fibromyalgia.
“We are pleased to be starting a Phase 2 clinical study in this indication, which is a growing problem and for which no drug is currently approved,” Dr. Seth Lederman, CEO of New Jersey-based Tonix, said at the unveiling of the Phase 2 trial news. “Our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with long COVID whose symptoms overlap with fibromyalgia.”
The Phase 2 study will last 14 weeks with patients taking sublingual tablets at bedtime. The trial, which will take place at approximately 30 sites across the United States, will involve about 470 patients with interim analysis expected in the first half of 2023.
“This retrospective observational database study also revealed the rate of opioid use in long COVID patients,” Dr. Greg Sullivan, chief medical officer of Tonix, said of the original medical research study on the use of opioids to treat long COVID. “We look forward to continuing to progress this (Tonix) study with the goal of developing a non addictive, centrally acting analgesic which potentially treats not only pain but also the sleep disturbance and fatigue that is common in long COVID.”
Major opioid producers in the U.S. include Johnson & Johnson JNJ and Cardinal Health Inc. CAH. Those two companies were included in a significant payout earlier this year to settle claims that they helped fuel the U.S. opioid crisis.
In April, President Biden issued an executive order to coordinate efforts to address long COVID across public and private sectors and to establish the first-ever interagency national research agenda to include work to develop new treatments. Congress had previously awarded the National Institutes of Health (NIH) $1.15 billion to study long COVID.
President Biden’s National Research Action Plan on Long COVID (National Research Action Plan (covid.gov) or www.covid.gov/assets/files/National-Research-Action-Plan-on-Long-COVID-08012022.pdf) contains numerous references on the overlap of Long COVID and chronic fatigue syndrome or ME/CFS, which is a chronic pain syndrome that overlaps with fibromyalgia.
In addition, while the vaccines available in the U.S. through either Food and Drug Administration approval or under emergency use authorization have been shown to prevent acute COVID, their ability to prevent long COVID is unknown, Tonix says.
Click here for more information on Tonix Pharmaceuticals: http://redingtonvirtual.com/tnxp-benzinga-7
Important notice, please read: Certain statements in this document are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.
Featured photo by Towfiqu Barbhuyia on Unsplash
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.