Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TNX-102 SL Tablet
TNX-102 SL · 16 trials · 21 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).
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).
| 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 |
| Placebo sublingual tablets | PLACEBO_COMPARATOR | Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime. |
| Placebo | PLACEBO_COMPARATOR | 2 x placebo tablet ("placebo") to be taken sublingually once 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 |
| 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. |
| Placebo sublingual tablet | DRUG | Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime. |
| Placebo | DRUG | - |
| 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. |
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...
TNX-102 SL is an investigational small molecule being developed for primary fibromyalgia, a chronic musculoskeletal condition. It is also being studied for post-acute sequelae of SARS-CoV-2 infection (PASC), major depressive episodes, and post-traumatic stress disorder (PTSD). The drug is administered as a sublingual tablet.
TNX-102 SL is being developed by Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company traded on NASDAQ under the ticker TNXP. The company is conducting clinical trials to evaluate the drug's safety and efficacy in several patient populations.
TNX-102 SL is in Phase 3 clinical development. It has completed Phase 2 and Phase 3 trials, including a Phase 2 study in fibromyalgia and a Phase 3 long-term safety study. The drug remains investigational and has not been approved by regulatory authorities.
TNX-102 SL has been studied in four clinical trials. These include NCT01903265, a Phase 2 study in fibromyalgia; NCT02015234, a Phase 3 open-label safety study; NCT02277704, a Phase 2 study in PTSD; and NCT02589275, a Phase 3 open-label study in fibromyalgia. All trials have been completed.
Yes, TNX-102 SL is also known as TNX-102 SL Tablet. The drug is formulated as a sublingual tablet, which is placed under the tongue for absorption. This alternative name is used in clinical trial documentation and regulatory filings.
TNX-102 SL is a small molecule, but its specific molecular target is not disclosed in the available information. The drug is being evaluated for its effects on fibromyalgia, PTSD, and other conditions, suggesting it may act on pathways relevant to these disorders.