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EN3270

Phase 2

Chronic, Non Malignant Pain | Small molecule | Oncology |DURECT Corporation|Last Updated: Feb 23, 2012

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00485225Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic PainPHASE2 COMPLETED 77Jun 1, 2007Jul 1, 2008Feb 23, 20121 United States
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Study Endpoints
Primary Endpoints
Safety and minimum titration period
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Transdermal patch (EN3270) - Titration 1EXPERIMENTAL -
Transdermal patch (EN3270) - Titration 2EXPERIMENTAL -
Transdermal patch (EN3270) - Titration 3EXPERIMENTAL -
Transdermal patch (EN3270) - Titration 4EXPERIMENTAL -
Interventions
NameTypeDescription
EN3270DRUGTransdermal Therapeutic System
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Opioid experienced * Hx (min 3 months) of moderate to severe pain of non-malignant that is well controlled with current pain therapy * On a stable dose of opioid medication for greater than or equal to 14 days * Have an adequate personal support system including a co-habitant ...

Countries:United States
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