In a milestone moment for chronic pain management, Tonix Pharmaceuticals announced on last August 15 that its novel sublingual therapy Tonmya has received approval from the american FDA, marking the first new drug for fibromyalgia in more than 15 years with an emphasis on improving “non-restorative” sleep, which is commonly implicated in fibromyalgia symptom burden. The medication is now commercially available by prescription in U.S. pharmacies, offering new hope to the roughly 10 million American adults affected by this debilitating condition. Tonmya represents a new therapeutic class: a non-opioid, once-daily sublingual tablet designed for bedtime use.
Importantly, Tonmya’s mechanism doesn’t rely on opioid pathways: its active molecule cyclobenzaprine, instead, it modulates receptors including serotonin (5-HT2A), adrenergic (α1R), histeminergic (H1R) and cholinergic (M1) types. Tonix notes that its formulation targets sleep architecture and central pain processing: a dual approach that could help address both pain and nonrestorative sleep, key components of fibromyalgia. The FDA’s approval rests on data from two Phase 3 randomized, double-blind, placebo-controlled trials (RELIEF and RESILIENT), which together enrolled nearly 1,000 adults with fibromyalgia.
In both trials, patients receiving Tonmya experienced statistically significant reductions in daily pain scores after 14 weeks compared to placebo -the primary endpoint. Moreover, a larger proportion of Tonmya-treated patients achieved a clinically meaningful ≥30% improvement in pain after three months. As Delcared by Tonix, the approval of Tonmya reflects the company’s long-term commitment to delivering a therapeutic advance that was overdue. This success mirrors broader trends in the non-opioid pain landscape, where the past year has seen multiple long-anticipated clinical milestones, signalling a transition from exploratory promise to real commercial viability.
One of the most notable being the recent FDA approval of Vertex’s suzetrigine (Journavx™), the first new non-opioid oral analgesic in decades. For the first time in over a decade, chronic pain research is no longer focused on a single mechanism. It has evolved into a multi-mechanistic, competitive landscape, featuring a diverse array of scientific approaches and therapeutic targets.
- Edited by Dr. Gianfrancesco Cormaci, PhD, specialist in Clinical Biochemistry.
Scientific references
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