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Duragesic

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 Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00857753Relative Bioavailability of a Fentanyl PatchPHASE1 COMPLETED 40 — — Sep 1, 2006Oct 1, 2006Mar 29, 2017 - —
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Study Endpoints
Primary Endpoints
Bioequivalence according to US FDA guidelines
3 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALFentanyl patch 25 ug/hr Sandoz
2ACTIVE_COMPARATORDuragesic Patch 25 ug/hr
Interventions
NameTypeDescription
Fentanyl patch 25 ug/nr SandozDRUG -
DuragesicDRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal findings on physical exam, medical history or clinical laboratory tests on screening. Exclusion Criteria: * Negative test for HIV and hepatitis B and C * No history of drug or alcohol treatment * No allergies to opiates

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