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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02589275 | A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients | PHASE3 | COMPLETED | 375 | — | — | Aug 4, 2015 | Sep 28, 2016 | Feb 20, 2025 | 33 | United States |
| NCT02015234 | 12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients | PHASE3 | COMPLETED | 158 | — | — | Dec 1, 2013 | Aug 1, 2015 | Jul 7, 2017 | 13 | United States |
| NCT01903265 | BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT) | PHASE2 | COMPLETED | 205 | — | — | Sep 1, 2013 | Sep 1, 2014 | Dec 23, 2016 | 17 | United States |
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 | 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. |
| Name | Type | Description |
|---|---|---|
| TNX-102 SL Tablet 2.8 mg | DRUG | TNX-102 SL 2.8 mg tablet taken daily at bedtime |
| TNX-102 SL | DRUG | TNX-102 SL 2.8 mg taken 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. |
| Placebo | DRUG | Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. |
Inclusion Criteria: * The patient met all prior inclusion and exclusion requirements for study F301 or F302 originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the e...