More than 40% of patients with long COVID report ‘fibromyalgia-like’ multi-site pain
Click Here to Manage Email Alerts
More than 40% of patients with long COVID experience “fibromyalgia-like,” multisite pain, according to data released by Tonix Pharmaceuticals.
The data — the result of an observational, retrospective database study involving more than 50,000 patients with long COVID symptoms — also demonstrate that a high rate of participants reported opioid use, according to the company.
“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 multisite pain,” Seth Lederman, MD, CEO of Tonix Pharmaceuticals, said in the release. “The finding that more than 40% of long COVID patients in this sample have fibromyalgia-like multisite 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.”
For the study, researchers analyzed data from the TriNetX Dataworks USA network, which contains medical records from 48 U.S. health care facilities. Out of 1 million patients in the network who were diagnosed with COVID-19, about 52,000 demonstrated long COVID symptoms between 3 and 6 months following acute infection, the release said.
Opioid use was observed in 36% of patients with multisite pain, compared with 19% of patients without multisite pain, according to the company. In addition, opioid use increased when fatigue (39%) or insomnia (50%) were present.
“These findings suggest that the group of long COVID patients with fibromyalgia-like multisite pain represents a significant portion of this underserved population,” Lederman said in the release. “Finally, the high level of opiate use reveals the urgency to provide effective non-opioid analgesia that is targeted toward widespread pain thought to be nociplastic in nature, meaning that augmented CNS pain and sensory processing, as well as altered pain modulation, play a role.”
Tonix recently announced the clearance of its investigational new drug application for its sublingual TNX-102 SL (cyclobenzaprine HCl) in patients whose long COVID symptoms appear to overlap with fibromyalgia.
Tonix anticipates the phase 2 trial to commence in the second quarter of 2022, the release said.
The company in March announced that TNX-102 SL had failed to achieve statistical significance in reducing fibromyalgia pain vs. placebo in a phase 3 trial.
Read more about
Click Here to Manage Email Alerts