Tonmya (cyclobenzaprine SL) / Tonix - LARVOL DELTA

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

TNX-102 SL Data Supports Recent Fibromyalgia Approval (HCPLive) - "The findings demonstrated that TNX-102 SL demonstrated significant improvement in the primary endpoint of change in weekly pain scores at Week 14 compared to placebo (P <.0001) in the RESILIENT trial. At Week 14, the least squares mean (LSM) weekly average of daily pain scores was 4.1 (95% CI, 3.8-4.3) for TNX102 SL compared to 4.7 (95% CI, 4.5-5.0) for placebo. LSM changes from baseline were -1.8 (95% CI, -2.0 to -1.6) for TNX-102 SL compared with -1.2 (95% CI, -1.4 to -0.9) for placebo...TX-102 SL was well-tolerated, with treatment emergent adverse events (TEAE)-related discontinuations occurring in 6.1% and 3.6% of subjects in the TNX-102 SL and placebo groups, respectively."

P3 data • Fibromyalgia

Randomized, double-blind, placebo-controlled confirmatory Phase 3 trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in fibromyalgia (PAINWeek 2025) - "TNX-102 SL significantly reduced FM pain at Week 14 (LS mean [SE] difference vs PBO of −0.7 [0.16]; P=0.00005; effect size=0.38). Significant improvements were also observed in PGIC (TNX-102 SL response 35.1% vs 19.1% PBO, P=0.0001); FIQR-S (P=0.000002); FIQR-F (P=0.001); PROMIS SD (P=0.0000001) and Fatigue (P=0.00009); and sleep quality (P=0.0007). Among exploratory endpoints, BDI-II total score (P=0.001, uncorrected) and the FIQR Memory item (P=0.001, uncorrected) were more improved with TNX-102 SL than PBO."

Clinical • P3 data • CNS Disorders • Cognitive Disorders • Depression • Musculoskeletal Pain • Pain • Psychiatry • Sleep Disorder

Steady-state pharmacokinetic properties of a sublingual formulation of cyclobenzaprine (CBP) HCl (TNX-102 SL): comparison to simulations of oral immediate-release CBP (PAINWeek 2025) - "On Day 20, mean C max and AUC at steady-state for CBP were 11.2 ng/mL and 175 h*ng/mL, respectively, for TNX-102 SL, with a T max of 5 h. For nCBP, mean C max and AUC were 10 ng/mL and 205 h*ng/mL, respectively. No unexpected AEs were observed with TNX-102 SL. Most of the AEs reported were mild in severity, and the majority of AEs resolved without treatment."

PK/PD data • CNS Disorders • Mood Disorders • Musculoskeletal Pain • Pain • Sleep Disorder

TNX-102 SL, cyclobenzaprine HCl sublingual tablets, demonstrates pain reduction and favorable tolerability in patients with fibromyalgia (PAINWeek 2025) - "Compared to placebo, TNX-102 SL demonstrated significant improvement in the primary pain endpoint (p< 0.0001) at Week 14. Female patients treated with TNX-102 SL had significantly greater improvements in desire/frequency (p=0.010), orgasm/completion (p=0.007), and total sexual function scores (p = 0.010). No significant differences in weight, systolic, or diastolic blood pressure were observed between TNX-102 SL and placebo at Week 14."

Clinical • CNS Disorders • Musculoskeletal Pain • Pain • Sleep Disorder

Sublingual cyclobenzaprine (TNX-102 SL) for fibromyalgia: efficacy and safety in two randomized placebo-controlled trials (PAINWeek 2025) - "In RESILIENT, compared to the placebo group, the TNX-102 SL group had a higher proportion of ≥30% responders (45.9% vs 27.1%; p < 0.001, uncorrected) and ≥50% responders (22.5% vs 13.3%; p =0.011, uncorrected). In RELIEF, the uncorrected p -value was 0.006 for ≥30% responder analysis and 0.141 for ≥50%. TNX-102 SL was generally well tolerated, with an AE profile that was similar to prior studies and was without new safety signals."

Clinical • CNS Disorders • Cognitive Disorders • Musculoskeletal Pain • Pain • Sleep Disorder

Exhibit Hall Social Break (PAINWeek 2025) - "This dedicated networking opportunity provides the perfect balance between professional development and relaxation. This break is sponsored by Tonmya."

CNS Disorders

Exhibit Hall Social Break and Raffle Drawing #2 (PAINWeek 2025) - "This dedicated networking opportunity provides the perfect balance between professional development and relaxation. This break is sponsored by Tonmya."

CNS Disorders

Exhibit Hall Social Break (PAINWeek 2025) - "Take a refreshing pause during your conference experience at our Exhibit Hall Social Break! This dedicated networking opportunity provides the perfect balance between professional development and relaxation.This break is sponsored by Tonmya."

CNS Disorders

Exhibit Hall Social Break and Raffle Drawing #2 (PAINWeek 2025) - "Sponsored By TONMYA Take a refreshing pause during your conference experience at our Exhibit Hall Social Break! This dedicated networking opportunity provides the perfect balance between professional development and relaxation.This break is sponsored by Tonmya."

CNS Disorders

PDM-06 - (Sponsored Breakfast Presentation) Optimizing Care in Fibromyalgia: Advancing Patient Outcomes from Diagnosis to Therapeutic Interventions (PAINWeek 2025) - "The program will also present clinical data on a novel therapeutic option, TNX-102 SL. Breakfast will be provided, and seats are limited. First come, first serve.This session is not certified for credit."

Clinical • CNS Disorders • Musculoskeletal Pain • Pain

Tonix Pharmaceuticals Announces FDA Approval of Tonmya (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia (GlobeNewswire) - "The approval incorporated efficacy from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of nearly 1,000 patients in total that evaluated Tonmya as a bedtime treatment for fibromyalgia....Tonmya is expected to be available for adult patients in the U.S. with fibromyalgia beginning in the fourth quarter of this year."

FDA approval • Launch US • Fibromyalgia

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 (GlobeNewswire) - P3 | N=457 | RESILIENT (NCT05273749) | Sponsor: Tonix Pharmaceuticals, Inc. | "Tonix Pharmaceuticals...announced that full results from its confirmatory Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia have been published online in the peer reviewed Pain Medicine....Participants received TNX-102 SL 2.8 mg for two weeks followed by 5.6 mg for twelve weeks, or matching placebo, with efficacy assessed over fourteen weeks. Treatment with TNX-102 SL produced a least-squares mean reduction of 1.8 points on the eleven-point daily pain numeric rating scale compared with a 1.2-point reduction for placebo, achieving the primary endpoint with high statistical significance. Statistically significant improvements were also observed across all six prespecified key secondary endpoints....TNX-102 SL was generally well tolerated."

P3 data • Fibromyalgia

Pain Relief by Targeting Nonrestorative Sleep in Fibromyalgia: A Phase 3 Randomized Trial of Bedtime Sublingual Cyclobenzaprine. (PubMed, Pain Med) - P3 | "Bedtime TNX-102 SL treatment was associated with significant improvements in fibromyalgia symptoms and function and was well tolerated."

Journal • P3 data • CNS Disorders • Fatigue • Fibromyalgia • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Rheumatology • Sleep Disorder

Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the Annual European Congress of Rheumatology (EULAR) 2025 (GlobeNewswire) - P3 | N=457 | RESILIENT (NCT05273749) | Sponsor: Tonix Pharmaceuticals, Inc. | "Tonix Pharmaceuticals Holding Corp...presented data in a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2025, held June 11-14, 2025, in Barcelona, Spain....The poster includes data from the RESILIENT Phase 3 study evaluating the efficacy and safety of TNX-102 SL with a primary endpoint of reducing daily pain numeric rating scale scores after 14 weeks of treatment. TNX-102 SL significantly reduced pain and improved clinical outcomes in fibromyalgia patients while demonstrating a favorable tolerability profile. TNX-102 SL employs a novel mechanism targeting the sleep disturbance in fibromyalgia by acting as a potent antagonist at four post-synaptic receptors, each of which is known to regulate sleep."

P3 data • Fibromyalgia

Advancing Fibromyalgia Treatment: Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL1) Targets Non-restorative Sleep and Provides Sustained Pain Reduction (EULAR 2025) - "In conclusion, TNX-102 SL was designed for transmucosal absorption of CBP in a long-term treatment regimen of daily bedtime dosing. By enhancing absorption, bypassing first pass metabolism and targeting the characteristic disturbed sleep of fibromyalgia, TNX-102 SL provides dynamic effects of CBP that appear to be less impacted by the background accumulation of norCBP compared to oral CBP. TNX-102 SL demonstrated consistent and durable reduction in pain over 14 weeks in two Phase 3 studies coupled with a favorable tolerability profile."

Fatigue • Fibromyalgia • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Rheumatology • Sleep Disorder

Tonix Pharmaceuticals Announces Poster Presentation at the Annual European Congress of Rheumatology (EULAR) 2025 (GlobeNewswire) - "Tonix Pharmaceuticals Holding Corp...today announced a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2025, being held June 11-14, 2025, in Barcelona, Spain. Details on the presentation can be found below."

Clinical data • Fibromyalgia

Tonix Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Highlights (GlobeNewswire) - "'Our focus continues to be on the upcoming U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on the market authorization on TNX-102 SL for the management of fibromyalgia. We are building out our commercial team for the anticipated product launch in the fourth quarter of this year'."

Launch US • Fibromyalgia

Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting (GlobeNewswire) - P=NA | N=NA | "In two pivotal randomized, placebo-controlled clinical trials, the efficacy of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) was assessed with a primary endpoint of reducing the weekly average of daily pain from baseline after 14 weeks of treatment using the numeric rating scale scores. In both studies, TNX-102 SL significantly reduced pain and improved clinical outcomes in fibromyalgia patients while demonstrating a favorable tolerability profile via a novel mechanism of targeting the sleep disturbance associated with fibromyalgia. TNX-102 SL is a potent antagonist at four post-synaptic receptors, each of which is involved in regulating sleep."

Clinical data • Fibromyalgia