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Oxymorphone immediate release

Phase 3

Acute Pain | Small molecule | Pain |BrainsWay Ltd.|Last Updated: Jan 2, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment320

FDA Designations

No designations recorded

Clinical trial landscape

Oxymorphone immediate release · 1 trial · 1 indication

Phase 3 1
NCT00226395Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute PainAcute Pain
COMPLETED320 Analytics
PHASE3COMPLETED
Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain
Acute Pain
NCT00226395320
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Study Endpoints

Primary Endpoints

Time to discontinuation due to all causes

Secondary Endpoints

The following are the secondary endpoints during the initial 6 hours following the first dose of study medication:
- 6-Hour Sum of Pain Intensity Differences (SPID; VAS and categorical)
- 6-Hour Total Pain Relief Scores (TOTPAR; VAS and categorical)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Oxymorphone immediate releaseDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Male or female patients 18 years of age or older * Patients undergoing surgery through an abdominal incision of at least 3 cm who are expected to be hospitalized for at least 36 hours and are expected to subsequently require at least 48 hours of oral opioid therapy. * Washout ...

Countries:United States
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Competitive Landscape -Acute Kidney Injury 14 trials (matched to "Acute Pain")

CompanyTickerTrialsLead PhaseDrugs
Fresenius Medical Care AG Sponsored ADRFMS2PHASE3Dialysis
AstraZeneca PLCAZN1PHASE2AZD4144
CalciMedica, Inc.CALC1PHASE2Auxora
Talphera, Inc.TLPH1N/AUndisclosed
SeaStar Medical Holding CorporationICU2 - Undisclosed
Collegium Pharmaceutical, Inc.COLL1 - Flozin
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Frequently asked questions about Oxymorphone immediate release

What is Oxymorphone immediate release used for?

Oxymorphone immediate release is an investigational small molecule being studied for the treatment of acute pain. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being evaluated for its efficacy and safety in managing post-surgical acute pain.

Who makes Oxymorphone immediate release?

Oxymorphone immediate release is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The drug is currently in Phase 3 clinical trials for the treatment of acute pain.

What phase is Oxymorphone immediate release in?

Oxymorphone immediate release is in Phase 3 clinical development. It is an investigational drug for acute pain and has not yet received FDA approval. The Phase 3 trial has been completed, with results not yet publicly reported.

What clinical trials is Oxymorphone immediate release in?

Oxymorphone immediate release has one completed Phase 3 clinical trial, NCT00226395, titled 'Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain.' The trial enrolled 320 participants in the United States and was randomized and double-blind.

Is Oxymorphone immediate release FDA approved?

Oxymorphone immediate release is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for acute pain. The completed Phase 3 trial, NCT00226395, evaluated its efficacy and safety in post-surgical acute pain, but approval status has not been established.