Tonix Pharmaceuticals announced it is opening a new Phase 3 trial to evaluate the efficacy and safety of its investigational therapy TNX-102 SL, a sublingual tablet, in easing the widespread pain linked to fibromyalgia.
Called RELIEF (NCT04172831) and taking place at sites across the U.S., the study is expected to enroll a first patient by year’s end.
TNX-102 SL is a non-opioid, non-addictive analgesic that acts on the central nervous system to decrease pain. It is a reformulation of the muscle relaxant compound cyclobenzaprine in a sublingual (under-the-tongue) form.
Should TNX-102 SL be approved by the U.S. Food and Drug Administration (FDA), it will be available under the brand name Tonmya.
The therapy is currently in Phase 2 trials for agitation in Alzheimer’s disease, and a Phase 3 study for post-traumatic stress disorder (PTSD).
The company previously tested TNX-102 SL in a Phase 2 (BESTFIT, NCT01903265) and Phase 3 (AFFIRM, NCT02436096) trial in fibromyalgia patients. Results indicated daily use at a 2.8 mg dosage helped to reduce patients’ pain and improve sleep quality.
But both studies failed to reach their primary goal of significant pain reduction at the 2.8 mg dose after 12 weeks of treatment, and Tonix decided to discontinue its development for fibromyalgia and to focus on PTSD.
Preliminary data from the Phase 3 PTSD trial (RECOVERY, NCT03841773) showed that a higher dose (2.8 mg twice daily for 5.6 mg total) had greater efficacy while retaining an acceptable safety and tolerability profile, the company announced in a press release.
Working with the FDA, Tonix was given guidance Tonix for advancing TNX-102 SL as a potential fibromyalgia treatment at the 5.6 mg dose.
“Initiating a new Phase 3 trial for TNX-102 SL in fibromyalgia is an important milestone … [as about] one-third of those diagnosed with fibromyalgia in the U.S. are reported to receive chronic prescription opiates, which is part of the opiate crisis, since opiates are not believed to be effective for central pain,” said Seth Lederman, MD, Tonix’s president and chief executive officer.
RELIEF will be a 14 week, placebo-controlled efficacy and safety study of TNX-102 SL at 5.6 mg (two 2.8 mg tablets) taken daily at bedtime in up to 470 adults, ages 18 to 65, with pain related to fibromyalgia.
For the first two weeks, all will be randomly assigned to either one tablet of TNX-102 or placebo, before moving to two daily tablets in their given study group. Enrollment and U.S. test site information is available here.
No serious and unexpected side effects have been reported at either dose, 2.8 mg or 5.6 mg, in the fibromyalgia or PTSD programs. The most common adverse events were transient oral numbness (hypoesthesia) or tingling (paresthesia), or abnormal “product taste” after dosing.
The therapy is also being considered as a possible treatment in alcohol use disorder.