Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TNX-102 SL Tablet, TNX-102 SL, TNX-102 SL at, Cyclobenzaprine tablets, Cyclobenzaprine, Cyclobenzaprine Tablet, Cyclobenzaprine HCl
TNX-102 SL (Tonmya) · 18 trials · 26 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).
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.
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.
Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)
Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose)
Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)
Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose)
Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-last dose).
Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-dose).
TEAEs will be collected throughout the study and are summarized descriptively by treatment, relationship, and severity for all subjects dosed.
Blood samples are collected from pre-dose on Day 1 up until Day 47 (648 hours post-last dose).
Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, and 48 hours post-dose. A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24 and 24-48 hours post-dose.
Every adverse events occurring during the study period will be reported.
| 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 |
| 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 | PLACEBO_COMPARATOR | Participants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of placebo in the ED as part of enrollment procedures. The placebo is the same formulation as active except the Cyclobenzaprine HCl content is replaced by Mannitol to maintain the same tablet weight and dimensions. 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. |
| TNX-102 SL 2.8 mg | EXPERIMENTAL | Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks. |
| A single 2.8 mg dose of TNX-102 SL, administered as one 2.8 mg sublingual tablet | EXPERIMENTAL | - |
| A single 5.6 mg dose of TNX-102 SL, administered as two 2.8 mg sublingual tablets | EXPERIMENTAL | - |
| Treatment A | EXPERIMENTAL | TNX-102 SL 2.8 mg, under fasting conditions |
| Treatment B | EXPERIMENTAL | TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fasting conditions |
| Treatment C | EXPERIMENTAL | TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fed conditions |
| Treatment A (TNX-102 SL) | EXPERIMENTAL | 2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days |
| Treatment B (AMRIX) | ACTIVE_COMPARATOR | 1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days |
| TNX-102 SL Tablets at 2.8 mg | EXPERIMENTAL | 1 x TNX-102 SL Tablets (with potassium phosphate) at 2.8 mg |
| TNX-102-B SL Tablets at 2.8 mg | EXPERIMENTAL | 1 x TNX-102-B SL Tablets (with sodium phosphate) at 2.8 mg |
| TNX-102-C SL Tablets at 2.8 mg | EXPERIMENTAL | 1 x TNX-102-C SL Tablets (with trisodium citrate) at 2.8 mg |
| Cyclobenzaprine tablets | ACTIVE_COMPARATOR | 1 x 5 mg cyclobenzaprine oral tablet |
| 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. |
| 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 | DRUG | Placebo 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. |
| 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. |
| TNX-102 SL Tablet | DRUG | CYCLOBENZAPRINE HYDROCHLORIDE SUBLINGUAL TABLET |
| Amrix 30 mg | DRUG | Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it. |
| TNX-102 SL Tablets at 2.8 mg | DRUG | 1 x TNX-102 SL Tablet (with potassium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
| TNX-102-B SL Tablets at 2.8 mg | DRUG | 1 x TNX-102-B SL Tablet (with sodium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
| TNX-102-C SL Tablets at 2.8 mg | DRUG | 1 x TNX-102-C SL Tablet (with trisodium citrate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
| Cyclobenzaprine tablets | DRUG | 1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Axsome Therapeutics, Inc. | AXSM | 1 | PHASE3 | AXS-14 |
TNX-102 SL is an investigational sublingual tablet being studied for several conditions, including major depressive episode, acute stress reaction, and fibromyalgia. It is also evaluated in healthy adult subjects for pharmacokinetic and tolerability purposes. It is not approved for any indication and remains in clinical development.
TNX-102 SL targets the 5-HT2A, alpha-1 adrenergic, H1 histamine, and M1 muscarinic receptors. Its active ingredient is cyclobenzaprine HCl, formulated as a sublingual tablet. By binding to these receptors, the drug is designed to modulate neurotransmitter activity, though its precise therapeutic effects are still under investigation.
TNX-102 SL is being developed by Tonix Pharmaceuticals Holding Corp., which trades on the Nasdaq under the ticker TNXP. The company is responsible for the clinical development of the sublingual cyclobenzaprine formulation across the studied indications.
TNX-102 SL is in Phase 2 clinical development. It has not been approved by the FDA or any regulatory agency. The program includes completed Phase 1 studies and ongoing Phase 2 trials in major depressive disorder and acute stress reaction, with one active trial currently recruiting.
TNX-102 SL has been studied in four clinical trials. Ongoing studies include NCT07621237, a Phase 2 trial in major depressive disorder, and NCT06636786, a Phase 2 trial in acute stress reaction. Completed trials include NCT07464535 and NCT07413367, both Phase 1 pharmacokinetic studies in healthy subjects.
TNX-102 SL is a sublingual tablet formulation of cyclobenzaprine HCl, so it contains the same active ingredient as cyclobenzaprine. However, TNX-102 SL is a specifically designed sublingual dosage form, distinct from oral cyclobenzaprine tablets. It is also known as Tonmya and TNX-102 SL tablets at 2.8 mg.