First Participant Enrolled in Study of Sublingual Cyclobenzaprine Hydrochloride for Potential Treatment of LongCOVID
The first participant has enrolled in the phase 2 PREVAIL study (NCT05472090) of cyclobenzaprine (TNX-102 SL1; Tonix Pharmaceuticals, Chatham, NJ) for a subset of people with long COVID syndrome who have fibromyalgia-like symptoms. Anticipated enrollment is 470 and participants will be randomly assigned to receive sublingual cyclobenzaprine or placebo daily (at bedtime) for 14 weeks.
A significant number of individuals with long COVID (more than 40%) experience fibromyalgia-like pain or headache disorderes both of which are thought to be mediated by central sensitization (central pain adaptation). Effects on pain will be assessed as change from baseline in the weekly average of daily self-reported worst pain intensity scores from baseline to week 14. Change in self-reported scores for sleep disturbance, fatigue, and cognitive function will also be evaluated. After the first half of enrolled participants complete the study, an interim analysis is expected for potential sample size reestimation or to stop the study early for efficacy.
“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. We believe long COVID, characterized by multisite pain, fatigue and sleep disturbance, has features of central sensitization syndromes similar to fibromyalgia. Fibromyalgia is considered one of the clusters of chronic overlapping pain conditions that have much in common with long COVID,” said Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals. “Findings from our retrospective observational database study . . .showed that more than 40% of long COVID patients in the sample have fibromyalgia-like multi-site pain symptoms, suggesting we should be able to recruit a robust cohort of participants to test the effects of TNX-102 SL in treating this condition. 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. We recognize the need to better understand and develop treatment for Long COVID.”
“This retrospective observational database study also revealed the rate of opioid use in long COVID patients,” said Greg Sullivan, MD, chief medical officer of Tonix Pharmaceuticals. “Opioid use was noted in 36% of Long COVID patients with multisite pain symptoms relative to 19% of long COVID patients without multisite pain. In those with multisite pain, opioid use increased to 39% of patients when fatigue was present, and 50% when insomnia was present. We look forward to continuing to progress this study with the goal of developing a nonaddictive, centrally acting analgesic which potentially treats not only pain but also the sleep disturbance and fatigue that are common in long COVID.”