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Oliceridine

Phase 3

Acute Pain | Small molecule | Pain |Trevena, Inc.|Last Updated: Oct 23, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment825
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02815709Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After BunionectomyPHASE3 COMPLETED 418 — — May 1, 2016Jan 1, 2017Sep 25, 20207 United States
NCT02820324Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After AbdominoplastyPHASE3 COMPLETED 407 — — May 1, 2016Jan 1, 2017Oct 23, 20205 United States
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Study Endpoints
Primary Endpoints
Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.
48 hours
Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo.
24 hours

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.

Secondary Endpoints
Number of Respiratory Safety Events Compared to Morphine.
48 hours
Duration of Respiratory Safety Events Compared to Morphine.
48 hours
Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine.
48 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment 1 OliceridineEXPERIMENTAL -
Treatment 2 OliceridineEXPERIMENTAL -
Treatment 3 OliceridineEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
MorphineACTIVE_COMPARATOR -
Treatment 4 PlaceboPLACEBO_COMPARATOR -
Treatment 5 MorphineACTIVE_COMPARATOR -
Interventions
NameTypeDescription
OliceridineDRUG -
PlaceboDRUG -
MorphineDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites7

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...

Countries:United States
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