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Also known as oliceridine
TRV130 · 6 trials · 3 indications
The NPRS is an 11-point scale from 0-10 where "0" = no pain and "10" = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit.
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS.
| Arm | Type | Description |
|---|---|---|
| Treatment 1 Oliceridine | EXPERIMENTAL | - |
| Treatment 2 Oliceridine | EXPERIMENTAL | - |
| Treatment 3 Oliceridine | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Morphine | ACTIVE_COMPARATOR | - |
| Treatment 4 Placebo | PLACEBO_COMPARATOR | - |
| Treatment 5 Morphine | ACTIVE_COMPARATOR | - |
| TRV130 | EXPERIMENTAL | For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed. For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval. |
| TRV130 1 mg | EXPERIMENTAL | TRV130 1 mg IV Q4H x 48 h |
| TRV130 2 mg | EXPERIMENTAL | TRV130 2 mg IV Q4H x 48 h |
| TRV130 3 mg | EXPERIMENTAL | TRV130 3 mg IV Q4H x 48 h |
| TRV130 4 mg | EXPERIMENTAL | TRV130 4 mg IV Q4H x 48 h |
| TRV130 1.5 mg | EXPERIMENTAL | TRV130 1.5 mg IV x 1 dose |
| TRV130 4.5 mg | EXPERIMENTAL | TRV130 4.5 mg IV x 1 dose |
| Name | Type | Description |
|---|---|---|
| Oliceridine | DRUG | - |
| Placebo | DRUG | - |
| Morphine | DRUG | - |
| TRV130 | DRUG | - |
| TRV130 1.5 mg | DRUG | TRV130 1.5 mg IV x 1 dose |
| TRV130 3 mg | DRUG | TRV130 3 mg IV x 1 dose |
| TRV130 4.5 mg | DRUG | TRV130 4.5 mg IV x 1 dose |
| Morphine 10 mg | DRUG | Morphine 10 mg IV x 1 dose |
Inclusion Criteria: * Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. * Experiences a pain intensity rating of moderate to severe acute pain. * Able to provide written informed consent before any study proc...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
TRV130 is an investigational small molecule being developed for the treatment of acute pain. Trevena, Inc. has studied it in patients with acute pain following surgical procedures, including abdominoplasty and bunionectomy, as well as in an open-label safety study in patients with acute pain.
TRV130 targets G protein coupled receptors, or GPCRs. It is a small molecule designed to act at this receptor class. This mechanism distinguishes it from conventional opioid analgesics that act at the mu-opioid receptor, though both approaches are used in acute pain management.
TRV130 is being developed by Trevena, Inc., which trades on the Nasdaq under the ticker TRVN. The company has sponsored the clinical program for TRV130, including Phase 1, Phase 2, and Phase 3 trials in acute pain and post-surgical pain settings.
TRV130 has completed Phase 3 clinical development. A Phase 3 open-label safety study in patients with acute pain has been completed, along with two Phase 2 studies and one Phase 1 pharmacokinetic and pharmacodynamic study. All four trials are listed as completed.
TRV130 has been evaluated in four completed trials: NCT02656875, a Phase 3 open-label safety study in acute pain enrolling 768 patients; NCT02335294, a Phase 2 study in pain after abdominoplasty; NCT02100748, a Phase 2 study in pain after bunionectomy; and NCT02083315, a Phase 1 study in healthy subjects.