Tonmya (cyclobenzaprine SL) / Tonix - LARVOL DELTA

Tonmya® (Cyclobenzaprine HCl Sublingual Tablets; CBP SL): Efficacy and Safety Analyses of CBP SL 2.8 mg and 5.6 mg in Adults with Fibromyalgia (ACR Convergence 2026) - No abstract available

Clinical • Fibromyalgia • Musculoskeletal Pain • Rheumatology

Tonmya® (TNX-102 SL; Cyclobenzaprine HCI Sublingual Tablets [CBP SL]) for the Treatment of Adults With Fibromyalgia: Number Needed to Treat, Numbers Needed to Harm and Likelihood to be Helped or Harmed: Results From a Pooled Analysis of Two Phase 3 Studies (ACR Convergence 2026) - No abstract available

P3 data • Retrospective data • Fibromyalgia • Musculoskeletal Pain • Rheumatology

Tonmya® (Cyclobenzaprine HCl Sublingual Tablets; CBP SL): Greater Absolute Pain Reduction with CBP SL 5.6 mg Compared to 2.8 mg in Adults with Fibromyalgia (PAINWeek 2026) - P2b, P3 | "The active treatment groups of the BESTFIT and AFFIRM studies included 103 and 262 patients, respectively, who took CBP SL 2.8 mg/d; the RELIEF and RESILIENT studies included 248 and 231 patients, respectively, who took CBP SL 5.6 mg/d. In BESTFIT, nightly CBP SL 2.8 mg treatment resulted in a LS mean (SE) weekly average NRS pain score reduction of -1.37 [0.21] points at Week 12; in AFFIRM, CBP SL 2.8 mg treatment resulted in a LS mean (SE) NRS pain score reduction of -1.40 [0.11] points at Week 12. In RELIEF, nightly CBP SL 5.6 mg treatment reduced the LS mean (SE) weekly average NRS pain score by -1.91 [0.12] points at Week 14."

Clinical • CNS Disorders • Musculoskeletal Pain • Pain

Tonmya® (TNX-102 SL; Cyclobenzaprine HCI Sublingual Tablets [CBP SL]) for the Treatment of Adults With Fibromyalgia: Number Needed to Treat, Numbers Needed to Harm and Likelihood to be Helped or Harmed: Results From a Pooled Analysis of Two Phase 3 Studies (PAINWeek 2026) - P3 | "In the pooled analysis, the NNT (95% CI) associated with a ≥ 30% pain reduction in adults with FM after 14 weeks of CBP SL treatment was 7 (5-12). The NNH associated with discontinuation due to AEs in adults with FM after 14 weeks of CBP SL treatment was 26 (14-110). The LHH, also known as NNT/NNH, was 3.7, suggesting a nearly four-fold greater likelihood of clinical benefit with CBP SL treatment for FM than treatment discontinuation."

P3 data • Retrospective data • CNS Disorders • Musculoskeletal Pain

The Drug Update: Recent drug approvals, summer 2026 edition. (PubMed, Nurse Pract) - "This article highlights the following new medications: brensocatib (Brinsupri), elinzanetant (Lynkuet), and zoliflodacin (Nuzolvence). Additionally, this article reviews newly approved indications for existing therapies, including finerenone (Kerendia) for heart failure with a left ventricular ejection fraction of >_ 40% and cyclobenzaprine hydrochloride sublingual tablets (Tonmya) for fibromyalgia."

Journal • Bronchiectasis • Cardiovascular • Congestive Heart Failure • Fibromyalgia • Heart Failure • Musculoskeletal Pain • Pain • Pulmonary Disease • Respiratory Diseases • Rheumatology

Sublingual Cyclobenzaprine for Fibromyalgia: Pharmacokinetic Rationale, Clinical Evidence, and Place in Therapy. (PubMed, Curr Pain Headache Rep) - "Meta-analyses encompassing four clinical trials have reported modest efficacy comparable to established agents such as duloxetine and pregabalin. By shifting adverse effects from systemic manifestations to predominantly local oral effects, the sublingual formulation may offer improved tolerability compared with oral cyclobenzaprine. TNX-102 SL appears particularly well suited for patients with sleep-predominant FM symptoms who have not responded adequately to or cannot tolerate existing first-line treatments."

Journal • PK/PD data • Review • CNS Disorders • Cognitive Disorders • Fatigue • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology • Sleep Disorder

Steady-state population pharmacokinetic modeling and simulation of a sublingual formulation of cyclobenzaprine (CBP) HCl (TNX-102 SL): comparison to simulations of oral immediate-release CBP (EULAR 2026) - "These data may explain why older trials of oral IR CBP HCl in fibromyalgia failed to show sustained effects on pain beyond a month. Moreover, they support the use of TNX-102 SL as a chronic bedtime treatment for fibromyalgia, which has been demonstrated to significantly reduce pain in fibromyalgia over 14 weeks in two pivotal Phase 3 trials, leading to FDA approval."

Clinical • PK/PD data • Fibromyalgia • Musculoskeletal Pain • Sleep Disorder

TNX-102 SL, cyclobenzaprine HCl sublingual tablets, demonstrates pain reduction and favorable tolerability in patients with fibromyalgia (EULAR 2026) - "Conclusions TNX-102 SL significantly reduced pain and fatigue, improved sleep and patient function, and showed a favorable tolerability profile in the RESILIENT study, including no meaningful impact on weight or blood pressure and improvement in some sexual function domains in females. Along with TNX-102 SL’s unique mechanism targeting nonrestorative sleep, these results support TNX-102 SL as a highly tolerable and effective treatment option for FM."

Clinical • Fibromyalgia • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Rheumatology • Sleep Disorder • Xerostomia

HORIZON: A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD) (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: Tonix Pharmaceuticals, Inc.

Monotherapy • New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

OASIS: Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: University of North Carolina, Chapel Hill | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Steady-State Pharmacokinetic Properties of TNX-102 SL, a Sublingual Tablet Formulation of Cyclobenzaprine Hydrochloride (HCl), With Daily Dosing in Healthy Volunteers: A Randomized, Open-Label Trial. (PubMed, Clin Pharmacol Drug Dev) - "Sublingual tablets and oral ER capsules had comparable metabolic profiles of Phase I and II metabolites in plasma over 20 days, with no unique metabolites by the sublingual route. Sublingual cyclobenzaprine HCl tablets were generally safe and well-tolerated."

Clinical • Journal • PK/PD data • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Cyclobenzaprine Reimagined: Clinical Insights Into Tonmya for Fibromyalgia. (PubMed, J Pharm Technol) - " Pharmacologic agents receive a weak recommendation for use in the treatment guidelines and include agents such as duloxetine, pregabalin, tramadol, amitriptyline, and a nonsublingual formulation of cyclobenzaprine. Tonmya, the newest agent approved for fibromyalgia, provides clinicians with an additional treatment option in a convenient dosage form for this potentially debilitating condition."

Journal • Review • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerability of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Japanese and Chinese Subjects (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Tonix Pharmaceuticals, Inc.

New P1 trial

Treatment with TNX-102 SL Produces Clinically Meaningful Improvements in Patient-Centered Outcomes in Fibromyalgia (PainConnect 2026) - No abstract available

Clinical • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Single-Dose Pharmacokinetic Assessment of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets): Results From Randomized, Open-Label Studies in Healthy Volunteers. (PubMed, Clin Pharmacol Drug Dev) - "Furthermore, this is the first report describing the active metabolite norcyclobenzaprine in clinical studies, showing an elimination half-life of ∼60 h. Oral hypoesthesia and abnormal taste were the most common adverse events. These findings support TNX-102 SL as a rapidly absorbed and efficient sublingual tablet formulation of cyclobenzaprine HCl, providing effective transmucosal delivery."

Journal • PK/PD data • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Tonix Pharmaceuticals, Inc.

New P1 trial

Sublingual cyclobenzaprine (Tonmya) for fibromyalgia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Current evidence on TNX-102 SL (cyclobenzaprine HCl sublingual) for fibromyalgia: strengths, limitations, and emerging hypotheses. (PubMed, Clin Rheumatol) - No abstract available

Journal • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Tonmya (cyclobenzaprine hydrochloride sublingual tablets): first FDA-approved therapy for fibromyalgia in over 15 years. (PubMed, Ann Med Surg (Lond)) - No abstract available

FDA event • Journal • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Short-term efficacy and safety of sublingual cyclobenzaprine for fibromyalgia: A systematic review and meta-analysis. (PubMed, Clin Rheumatol) - "This meta-analysis of TNX-102 SL for fibromyalgia found that once-nightly sublingual cyclobenzaprine produced consistent improvements in pain response and global impression compared to placebo, with a good tolerability profile. TNX-102 SL represents an essential new non-opioid option for fibromyalgia. Key Points • In a meta-analysis of four randomized, double-blind trials (n = 1,684), TNX-102 SL increased ≥ 30% and ≥ 50% pain responder rates versus placebo (RR 1.44 and 1.43; low heterogeneity). • TNX-102 SL improved Patient Global Impression of Change (RR 1.52), while FIQ-R scores -were not significantly different from placebo. • Treatment-emergent adverse events were more frequent and primarily transient oral effects (hypoesthesia, paresthesia, dysgeusia), with similar discontinuation rates and no reportd deaths."

Clinical • Journal • Retrospective data • Fatigue • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder (GlobeNewswire) - "Tonix plans to initiate potential pivotal Phase 2 HORIZON study of TNX-102 SL in adults with major depressive disorder in mid-2026...The study will compare TNX-102 SL 5.6 mg, taken sublingually at bedtime to placebo, with the primary endpoint being the MADRS total score change from baseline at Week 6. Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep disturbance."

IND • New P2 trial • Major Depressive Disorder

Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment (Tonix Pharma Press Release) - "TONMYA is a first-in-class treatment for fibromyalgia in adults as a non-opioid analgesic taken once daily at bedtime."

Launch US • Fibromyalgia

TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Patients with Fibromyalgia (ACR Convergence 2025) - "TNX-102 SL significantly reduced pain and showed a favorable tolerability profile, including minimal impact on weight and blood pressure, along with its unique mechanism targeting sleep disturbances, supports its potential as a new treatment option for FM. The availability of a well-tolerated treatment may also encourage clinicians to make the diagnosis of fibromyalgia earlier, thereby improving patient outcomes through timely intervention."

Clinical • CNS Disorders • Fibromyalgia • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Rheumatology • Sleep Disorder

Efficacy and safety of TNX-102 SL in patients with fibromyalgia: a systematic review and meta-analysis. (PubMed, Pain Manag) - "TNX-102 SL is a new sublingual tablet formulation of cyclobenzaprine (CBP) for rapid transmucosal absorption. Pooled data show TNX-102 SL significantly reduces pain, improves sleep quality, and enhances quality of life in FM patients. www.crd.york.ac.uk/prospero identifier is CRD42024588069."

Journal • Retrospective data • Review • Anesthesia • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Tonix Pharmaceuticals…announced successful completion of a Pre-IND meeting with the FDA regarding TNX-102 SL for treating major depressive disorder (MDD). (StockTitan.net) - "The company plans to file an IND application in Q4 2025 and pursue a supplemental new drug application (sNDA) to expand TNX-102 SL's indication to include MDD...Phase 2 trials to follow shortly thereafter..."

IND • Major Depressive Disorder