Over 40% of Long COVID Patients Had Fibromyalgia-Like Symptoms

New Jersey-based Tonix Pharmaceuticals Holding Corp. recently announced today the results of a retrospective observational database study in over 50,000 patients diagnosed with Long COVID, the Post-Acute Sequelae of COVID-19 (PASC3).

The goal of the retrospective database study was to assess the proportion of Long COVID patients who experience fibromyalgia-like multi-site pain and to measure their use of opiates.

In the study, over 40% of patients with symptoms of Long COVID had fibromyalgia-like multi-site pain.

In addition, the study reported on the rate of opioid use in Long COVID patients.

Opioid use was noted in 36% of Long COVID patients with multi-site pain symptoms relative to 19% of Long COVID patients without multi-site pain.

In patients with multisite pain, opiate use increased to 39% of patients when fatigue was present and 50% of patients when insomnia was present.

“We undertook this retrospective analysis to determine the feasibility and representative nature of our upcoming Phase 2 study of TNX-102 SL in patients with Long COVID who present with fibromyalgia-like multi-site pain,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, in a press release issued on April 20, 2022.

“The finding that more than 40% of Long COVID patients in this sample have fibromyalgia-like multi-site pain symptoms suggests that we should be able to recruit a robust cohort of participants to test the effects of TNX-102 SL in treating this condition."

"Further, these findings suggest that the group of Long COVID patients with fibromyalgia-like multi-site pain represents a significant portion of this underserved population."

"Finally, the high level of opiate use reveals the urgency to provide effective non-opioid analgesia targeted toward widespread pain thought to be nociplastic in nature, meaning that augmented CNS pain and sensory processing and altered pain are augmented modulation plays a role."

"The upcoming Phase, 2 study's primary efficacy endpoint will therefore be changed from baseline in the weekly average of daily self-reported worst pain intensity scores.”

The study queried data from the TriNetX Dataworks USA Network. 

Tonix recently announced that the U.S. FDA had cleared the Investigational New Drug application to support a Phase 2 clinical trial with TNX-102 SL4 (cyclobenzaprine HCl tablets for sublingual administration) as a potential treatment for a subset of patients with Long COVID whose symptoms overlap with fibromyalgia, and expects to initiate this study in the second quarter of 2022.

Note: This press release was edited for clarity and manually curated for mobile readership.