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oxymorphone

Phase 1

Pain | Small molecule | Pain |Novartis AG|Last Updated: Mar 29, 2017

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment82
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00857142Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed ConditionsPHASE1 COMPLETED 32 — — Nov 1, 2007Dec 1, 2007Mar 29, 2017 - —
NCT00857428Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted ConditionsPHASE1 COMPLETED 50 — — Nov 1, 2007Dec 1, 2007Mar 29, 2017 - —
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Study Endpoints
Primary Endpoints
Bioequivalence according to US FDA guidelines
Two weeks
Bioequivalence based on Cmax and AUC
Four Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALOxymorphone hydrochloride 40 mg extended release tablets (Sandoz)
2ACTIVE_COMPARATOROpana 40 mg extended release tablets
Interventions
NameTypeDescription
oxymorphone hydrochlorideDRUG -
OpanaDRUG -
oxymorphoneDRUGTablets
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal findings on physical exam, nonmedical history or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C * Treatment for drug or alcohol abuse * Allergy to opiates

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