Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05273749 | A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia | PHASE3 | COMPLETED | 457 | — | — | Apr 6, 2022 | Nov 14, 2023 | Jan 22, 2025 | 33 | United States |
| NCT04508621 | A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia | PHASE3 | COMPLETED | 514 | — | — | Jul 22, 2020 | Nov 1, 2021 | Dec 18, 2023 | 36 | United States |
| NCT04172831 | A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia | PHASE3 | COMPLETED | 503 | — | — | Dec 9, 2019 | Oct 29, 2020 | Aug 8, 2022 | 39 | United States |
| NCT02436096 | A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia | PHASE3 | COMPLETED | 519 | — | — | Apr 1, 2015 | Sep 1, 2016 | Feb 7, 2025 | 35 | United States |
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).
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).
| 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 Tablet, 2.8 mg | EXPERIMENTAL | 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks |
| 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 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. |
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 |
| Grace Therapeutics, Inc. | GRCE | 1 | — | Undisclosed |