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TRV130 · 5 trials · 4 indications
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 |
|---|---|---|
| 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. |
| Morphine | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 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 |
| Part A | EXPERIMENTAL | Fixed sequence, open label |
| Part B | EXPERIMENTAL | 4 way cross over, double blind |
| 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 |
|---|---|---|
| TRV130 | DRUG | - |
| Morphine | DRUG | Rescue: Ibuprofen, oxycodone |
| Placebo | DRUG | Rescue: Ibuprofen, oxycodone |
| Moxifloxacin | 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 include: * Moderate to severe acute pain for which parenteral opioid therapy is warranted * Able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure. Exclusion Criteria include: * Clinically sig...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 1 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| Talphera, Inc. | TLPH | 1 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
TRV130 is an investigational small molecule being developed for the treatment of acute pain. It has been studied in patients with pain after bunionectomy and abdominoplasty, as well as in healthy volunteers. The drug is still in clinical development and has not been approved by the FDA.
TRV130 is being developed by Trevena, Inc., a biopharmaceutical company. Trevena's stock is traded under the ticker symbol TRVN on the NASDAQ.
TRV130 is in Phase 3 clinical development. It has completed Phase 1, Phase 2, and Phase 3 trials. However, it remains an investigational drug and is not yet approved by the FDA for any use.
TRV130 has been studied in several clinical trials, including NCT02100748 for pain after bunionectomy, NCT02335294 for pain after abdominoplasty, NCT02344303 for effects on QTc intervals in healthy volunteers, and NCT02656875 for safety in patients with acute pain. All trials are completed.
TRV130 is also known as oliceridine. It is an investigational small molecule being developed by Trevena, Inc. for the treatment of acute pain.