Reprinted with the kind permission of Donna Gregory Burch and Fed Up with Fatigue.
A novel, non-opioid analgesic is on track to become the first newly approved pharmaceutical treatment for fibromyalgia in more than a decade.
Last month, Tonix Pharmaceuticals Holding Corp. announced TNX-102 SL, a sublingual version of the common muscle relaxer cyclobenzaprine (brand name: Flexeril), met its primary goal of relieving pain during a randomized, double-blind, placebo-controlled trial.
The 14-week RELIEF trial enrolled around 500 participants at 39 sites across the country. During the first two weeks of RELIEF, participants received 2.8 mg of TNX-102 SL or a placebo pill. For the remaining 12 weeks of the trial, participants received either 5.6 mg of TNX-102 SL or placebo.
Nearly 47% of participants who received the 5.6 mg dose reported a 30% or greater reduction in pain.
“TNX-102 SL at 5.6 mg showed statistically significant and clinically meaningful improvement on the primary endpoint of reducing daily pain as well as showed activity in key secondary endpoints of improving sleep and reducing fatigue,” said Dr. Seth Lederman, president and CEO of Tonix Pharmaceuticals. “One of the biggest challenges in drug development is finding a dose that balances efficacy and tolerability. We are pleased with the consistent effects of TNX-102 SL 5.6 mg on the primary endpoint of daily pain as well as the tolerability of this dose in the RELIEF study.”
The most commonly reported side effects included tongue/mouth numbness and tingling, tongue/mouth pain/discomfort and taste impairment. These side effects were temporary and generally disappeared within an hour of taking TNX-102 SL.
Tonix is currently recruiting for a second 14-week trial called RALLY, which will follow the same timeline and dosing as the RELIEF study.
Fibromyalgia patients who are interested in participating in the trial should visit RallyStudy.com for more information.
In 2016, it appeared TNX-102 SL wouldn’t come to market as a fibromyalgia treatment after the drug failed to meet the threshold for pain relief when given at a lower dose of 2.8 mg. But instead of giving up entirely on the potential of TNX-102 SL, Tonix launched two new phase 3 trials last year using 5.6 mg in hopes the higher dose would have greater pain-fighting ability.
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While many pharmaceutical companies halted their clinical trials due to the COVID-19 pandemic, Tonix continued the RELIEF trial through last spring and into the early fall.
As RELIEF was winding down, Tonix began recruiting fibromyalgia patients for the RALLY trial. The company is hopeful that completing the identical studies back-to-back will help the company satisfy U.S. Food and Drug Administration (FDA) requirements and bring TNX-102 SL to market as quickly as possible.
If the RELIEF and RALLY trials are both successful, Tonix plans to submit a new drug application to the FDA next year seeking approval for TNX-102 SL as a fibromyalgia treatment.
Results from RALLY are expected during the second half of 2021.
TNX-102 SL targets the disturbed sleep of fibromyalgia patients, which in turn should lead to reductions in pain, fatigue and other symptoms.
“The sleep disorder specific to fibromyalgia has been called ‘non-restorative’ sleep,” Lederman explained. “Dr. Harvey Moldofsky, professor emeritus of psychiatry and medicine at the University of Toronto, founding director of the University of Toronto Center for Sleep and Chronobiology and member of the Tonix Scientific Advisory board, first recognized the central role of non-restorative sleep in the pathogenesis of fibromyalgia.
“Our program is based on the subsequent pioneering work of Dr. Iredell W. Iglehart III, assistant professor of medicine, part-time, division of rheumatology, Johns Hopkins School of Medicine and member of the Tonix Scientific Advisory Board, who recognized that a sleep-focused cyclobenzaprine treatment protocol had the potential to target non-restorative sleep and lead to improvement of fibromyalgia at the syndromal level,” Lederman continued.
It’s been more than a decade since the FDA has approved a new treatment for fibromyalgia, and patients are desperately in need of new solutions to manage chronic pain.
“TNX-102 SL has the potential to be a new non-addictive, non-opiate analgesic for the management of fibromyalgia which is particularly important given that fibromyalgia is a chronic pain condition,” said Dr. Gregory Sullivan, chief medical officer of Tonix. “Approximately one-third of fibromyalgia patients resort to opiates out of desperation and because of dissatisfaction with available therapies. Cyclobenzaprine, the active ingredient of TNX-102 SL, has no recognized potential for addiction. …TNX-102 SL could potentially offer fibromyalgia patients who have multiple disabling fibromyalgia symptoms a first-line monotherapy with broad symptom relief and the compliance advantage of being administered once a day [at bedtime].”