Business
Tonix Pharmaceuticals Announces Results of Retrospective Observational Database Study In Over 50,000 Long COVID Patients
Over 40% of Long COVID Patients Had Fibromyalgia-Like Multi-Site Pain Symptoms Rate of Opioid Use in Long COVID Patients with Multi-Site Pain is a Potential
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Over 40% of Long COVID Patients Had Fibromyalgia-Like Multi-Site Pain Symptoms Rate of Opioid Use in Long COVID Patients with Multi-Site Pain is a Potential Health Concern CHATHAM, N.J., April 20, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today the results of a retrospective observational database study in over 50,000 patients diagnosed with Long COVID1-2. Long COVID is known officially as Post-Acute Sequelae of COVID-19 (PASC3). Tonix recently announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) 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. 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 1,2. In addition, the study reported on the rate of opioid use in Long COVID patients. Opioid use noted was 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 in part 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. “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 ...