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Label indication OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )] , and persist over the course of therapy, reserve opioid analgesics,… FDA label
Also known as TRV130
Oliceridine · 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 |
Oliceridine is an investigational small molecule being developed for the treatment of moderate to severe acute pain. It has been studied in Phase 3 clinical trials in patients with acute pain following surgical procedures, including abdominoplasty and bunionectomy. It is not yet approved for commercial use.
Oliceridine targets OPRM1, the mu-opioid receptor. It acts as an agonist at this receptor, meaning it activates the receptor to produce its pharmacological effect. OPRM1 agonism is the established mechanism underlying opioid analgesia, and oliceridine was designed to engage this target for the management of acute pain.
Oliceridine is being developed by Trevena, Inc., a biopharmaceutical company that trades under the ticker symbol TRVN. Trevena sponsored the Phase 3 clinical program evaluating oliceridine in acute pain following surgery.
Oliceridine is in Phase 3 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 3 program consists of completed trials in acute pain, and no trials are currently listed as active.
Oliceridine has been evaluated in two completed Phase 3 trials: NCT02820324, which studied it for moderate to severe acute pain after abdominoplasty, and NCT02815709, which studied it for moderate to severe acute pain after bunionectomy. Together these trials enrolled 825 participants across sites in the United States.
Yes, oliceridine is also known as TRV130. The two names refer to the same investigational small molecule developed by Trevena, Inc. for acute pain. Trial titles and publications may use either name, so searches for TRV130 and oliceridine refer to the same drug candidate.