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Label indication TONMYA ® is indicated for treatment of fibromyalgia in adults. TONMYA is indicated for the treatment of fibromyalgia in adults ( 1 ).
Also known as TNX-102 SL Tablet, TNX-102 SL, Cyclobenzaprine tablets, Cyclobenzaprine, Cyclobenzaprine Tablet, Cyclobenzaprine HCl
TNX-102 SL (Tonmya) · 13 trials · 20 indications
Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.
Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Evaluate the incidence of newly emergent adverse events over an additional 40 weeks of treatment with TNX-102 SL 5.6 mg in patients with PTSD who have participated in a double-blinded lead-in study. Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class. Serious AEs and AEs leading to discontinuation of study drug will also be summarized.
The number of patients with at least one adverse event which began after the first dose of TNX-102 SL in this open-label extension study.
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement (responder criteria) from baseline to Week 12 in the weekly mean of the daily self-reported 24-hour recall average pain intensity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).
Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.
Individuals are asked to complete the 14-item Acute Stress Disorder Scale (ASDS) self-report inventory where each item is rated on a 5-point scale (0= Not at all; 1= Mildly; 2= Medium; 3= Quite a bit; 4= Very Much) that indexes acute stress disorder (ASD). Range of possible total scores is 0-56, with higher total scores indicating greater acute stress symptoms.
Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
Change from Baseline in the diary Numeric Rating Scale (NRS) weekly average of daily self-reported worst Long COVID pain intensity scores at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome.
Number of patients with new treatment emergent AEs since completing lead-in study
The mean change from baseline (Visit 2) in the Total CAPS-5 score after 12 weeks of treatment evaluated at Visit 9 (Week 12). The primary efficacy comparison will be the change from baseline in total CAPS-5 score for the 2.8 mg treatment arm compared to placebo. CAPS-5 score ranges from 0-80 with lower scores indicating less severe PTSD symptoms.
| Arm | Type | Description |
|---|---|---|
| TNX-102 SL Tablet, 5.6 mg | EXPERIMENTAL | 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks. |
| Placebo SL Tablet | PLACEBO_COMPARATOR | 1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks. |
| TNX-102 SL Tablets, 5.6 mg | EXPERIMENTAL | 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks. |
| TNX-102 SL 5.6 mg | EXPERIMENTAL | 2 tablets of TNX-102 SL 2.8 mg taken simultaneously and sublingually (under the tongue) each day at bedtime starting on Day 0 for 40 weeks |
| TNX-102 SL Tablet 2.8 mg | EXPERIMENTAL | 1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 3 months |
| TNX-102 SL Tablet, 2.8 mg | EXPERIMENTAL | 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks |
| TNX-102 SL | EXPERIMENTAL | 1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months |
| TNX-102 SL 2.8 mg | EXPERIMENTAL | Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks. |
| Cyclobenzaprine HCl | EXPERIMENTAL | Participants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of Cyclobenzaprine HCl in the ED as part of enrollment procedures. If the time between the first half dose and the planned bedtime of the participant is less than 6 hours, participants will be instructed to take 1 tablet (half dose) the first night at bedtime. If the time between the first half dose and planned bedtime of the participant is greater than or equal to 6 hours, then participants will be instructed to take a full dose (equivalent to 2 tablets) the first night. Over the following 13 days, all participants will be instructed to take a full dose of the study drug at bedtime. Each participant will receive 29 tablets and take either 28 or 29 tablets total for the duration of study participation. |
| Placebo sublingual tablets | PLACEBO_COMPARATOR | Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime. |
| TNX-102 SL, 2.8 mg | ACTIVE_COMPARATOR | 1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. |
| TNX-102 SL, 5.6 mg | ACTIVE_COMPARATOR | 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime. |
| Name | Type | Description |
|---|---|---|
| TNX-102 SL Tablet, 5.6 mg | DRUG | Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. |
| Placebo SL Tablet | DRUG | Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks. |
| TNX-102 SL | DRUG | Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks. |
| TNX-102 SL 5.6 mg | DRUG | cyclobenzaprine HCl sublingual tablets |
| TNX-102 SL Tablet 2.8 mg | DRUG | TNX-102 SL 2.8 mg tablet taken daily at bedtime |
| TNX-102 SL Tablet, 2.8mg | DRUG | Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks. |
| TNX-102 SL 2.8mg | DRUG | Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. |
| Placebo | DRUG | Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. |
| Cyclobenzaprine HCl | DRUG | TNX-102 SL (cyclobenzaprine HCl sublingual tablets) taken sublingually (under the tongue) in the ED and each day at bedtime for a total of 2 weeks. |
| Placebo sublingual tablet | DRUG | Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime. |
Inclusion Criteria: * The patient is male or female 18 to 65 years of age, inclusive. * The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria) Exclusion Criteria...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Axsome Therapeutics, Inc. | AXSM | 2 | PHASE3 | AXS-14 |
TNX-102 SL, also called Tonmya, is an investigational sublingual tablet formulation of cyclobenzaprine HCl developed by Tonix Pharmaceuticals Holding Corp. (TNXP). It is a small molecule being studied across several conditions, including fibromyalgia, major depressive episode, PTSD, acute stress reaction, and post-acute sequelae of SARS-CoV-2 infection. It remains in clinical development.
TNX-102 SL targets the 5-HT2A, alpha-1 adrenergic, H1 histamine, and M1 muscarinic receptors. It is a sublingual formulation of cyclobenzaprine HCl, a small molecule that binds these receptor sites. This receptor profile is the basis for its investigation across pain, sleep, and stress-related conditions.
Tonix Pharmaceuticals Holding Corp., which trades under the ticker TNXP, is developing TNX-102 SL. The company is the sponsor of the clinical program studying the sublingual cyclobenzaprine tablet across fibromyalgia, major depressive episode, PTSD, acute stress reaction, and post-acute sequelae of SARS-CoV-2 infection.
TNX-102 SL is investigational and remains in clinical development. Its program includes Phase 2 studies in major depressive episode, acute stress reaction and PTSD, and post-acute sequelae of SARS-CoV-2 infection, plus a completed Phase 3 study in fibromyalgia. It is not approved for any indication based on the development stage reported.
TNX-102 SL has been studied in four trials. NCT07621237 is a recruiting Phase 2 monotherapy study in major depressive disorder, and NCT06636786 is a recruiting Phase 2 study in acute stress reaction and PTSD. NCT05472090 was a completed Phase 2 PASC study, and NCT05273749 was a completed Phase 3 fibromyalgia study.
TNX-102 SL is a sublingual tablet formulation of cyclobenzaprine HCl, so it is also known as cyclobenzaprine tablets and TNX-102 SL. The names TNX-102 SL 2.8 mg, TNX-102 SL 5.6 mg, and TNX-102 SL Tablet refer to the same investigational product developed by Tonix Pharmaceuticals.