Tonix Pharmaceuticals Holding Corp. has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, centrally-acting analgesic, for the management of fibromyalgia. The submission is based on data from two successful Phase 3 clinical trials demonstrating statistically significant reductions in daily pain compared to placebo, with the drug being generally well-tolerated.
Efficacy and Safety Data
The NDA is supported by data from two 14-week, double-blind, randomized, placebo-controlled Phase 3 clinical trials. The prior Phase 3 RELIEF trial of TNX-102 SL in fibromyalgia met its pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p=0.010). The confirmatory Phase 3 RESILIENT study in fibromyalgia also met its pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p =0.00005). In both trials, TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies and with no new safety signals observed.
Mechanism of Action and Potential Benefits
TNX-102 SL is designed as a bedtime treatment to target non-restorative sleep, a characteristic feature of fibromyalgia. It is a sublingual formulation of cyclobenzaprine hydrochloride, interacting with serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors in the brain. This mechanism is believed to address the underlying sleep disturbances associated with fibromyalgia.
Addressing Unmet Needs in Fibromyalgia Treatment
Fibromyalgia affects more than 10 million adults in the U.S., predominantly women. Current treatments include gabapentinoids and SNRIs, but there remains a need for new options. If approved, TNX-102 SL would be the first in a new tricyclic class of medicines for treating fibromyalgia, offering a novel approach to pain management in this patient population.
Regulatory Timeline
The FDA typically has a 60-day filing review period to determine whether the submitted NDA is complete and accepted for review. If FDA accepts the NDA for review, the Company expects a 2025 date for an FDA decision on approval, based on the Prescription Drug User Fee Act (PDUFA).
