TNX-102 SL FDA Approval Status

Last updated by Judith Stewart, BPharm on July 15, 2025.

FDA Approved: No
Brand name: TNX-102 SL
Generic name: cyclobenzaprine hydrochloride
Company: Tonix Pharmaceuticals Holding Corp.
Treatment for: Fibromyalgia

TNX-102 SL (cyclobenzaprine hydrochloride) is a sublingual formulation of cyclobenzaprine hydrochloride in development for the treatment of pain associated with fibromyalgia.

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).
Cyclobenzaprine hydrochloride 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-HT_2A, 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.
TNX-102 SL is a new 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, TNX-102 SL provides a rapid onset of action, avoids first-pass hepatic metabolism, and reduces the formation of norcyclobenzaprine (nCBP), a long-lived active metabolite which is associated with unfavorable side effects.
A New Drug Application (NDA) for TNX-102 SL for the treatment of fibromyalgia has been accepted by the U.S. Food and Drug Administration (FDA). The NDA was supported by positive data from the Phase 3 RELIEF and RESILIENT trials. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025.
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 TNX-102 SL

Date	Article
Jul 9, 2025	Tonix Pharmaceuticals Announces On-line Publication of Phase 3 RESILIENT Trial Results of TNX-102 SL for Fibromyalgia in the Peer Reviewed Journal, Pain Medicine
Dec 23, 2024	Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia
Dec 17, 2024	Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia
Oct 16, 2024	Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA)
Dec 20, 2023	Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia
Apr 24, 2020	Tonix Pharmaceuticals Achieves 50 Percent Enrollment in Phase 3 RELIEF Study of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) for Management of Fibromyalgia
Jul 6, 2017	Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya as Proposed Brand Name for TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) for the Treatment of PTSD
May 30, 2017	Tonix Pharmaceuticals Presented Retrospective Analyses of Treatment Response and Remission to TNX-102 SL in a Phase 2 Military-Related PTSD Study
Jun 10, 2014	Tonix Pharmaceuticals Receives IND Clearance From FDA for TNX-102 in Post-Traumatic Stress Disorder

Further information

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