Tonmya FDA Approval History
FDA Approved: Yes (First approved August 15, 2025)
Brand name: Tonmya
Generic name: cyclobenzaprine hydrochloride
Previous Name: TNX-102 SL
Company: Tonix Pharmaceuticals Holding Corp.
Treatment for: Fibromyalgia
Last updated by Judith Stewart, BPharm on Aug 18, 2025.
Tonmya (cyclobenzaprine hydrochloride) is a sublingual formulation of cyclobenzaprine hydrochloride indicated for the treatment of fibromyalgia in adults.
- Fibromyalgia is a common chronic pain condition thought to result from amplified sensory and pain signaling within the central nervous system. Symptoms include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction).
- Tonmya contains cyclobenzaprine hydrochloride, which is thought to improve the non-restorative sleep characteristic of fibromyalgia through potent binding and antagonist activities at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors.
- Cyclobenzaprine hydrochloride was first approved in 1977 for the relief of skeletal muscle spasm. Cyclobenzaprine hydrochloride has been approved under the brand names Flexeril (5 mg and 10 mg tablets) and Amrix (15 mg and 30 mg extended release capsules) and generics.
- Tonmya is a rapidly-disintegrating, sublingual formulation of cyclobenzaprine hydrochloride 2.8 mg designed for bedtime dosing to target disturbed sleep in fibromyalgia patients, while reducing the risk of daytime somnolence. It is is based on a eutectic formulation of cyclobenzaprine hydrochloride and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine efficiently into the bloodstream. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine formulations, Tonmya provided a rapid onset of action, avoided first-pass hepatic metabolism, and reduced the formation of norcyclobenzaprine (nCBP), a long-lived active metabolite which is associated with unfavorable side effects.
- FDA approval of Tonmya was supported by efficacy data from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of nearly 1000 patients. Across both trials, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo.
- Tonmya tablets are administered sublingually, once daily at bedtime.
- Warnings and precautions associated with Tonmya include embryofetal toxicity, serotonin syndrome, tricyclic antidepressant-like adverse reactions, atropine-like adverse reactions, CNS depression, and oral mucosal adverse reactions.
- Common adverse reactions (incidence ≥2% and at a higher incidence in Tonmya-treated patients compared to placebo-treated patients) include oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
- TNX-102 SL is also being studied as a treatment for PTSD, alcohol use disorder, acute stress disorder, and agitation in Alzheimer’s disease (AAD).
Development timeline for Tonmya
Further information
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