Recent Updates
Recently added Catalysts

ORAVESCENT Fentanyl

Phase 3

Chronic Low Back Pain | Small molecule | Musculoskeletal |Teva Pharmaceutical Industries Limited|Last Updated: May 9, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00214942Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough PainPHASE3 COMPLETED -Sep 1, 2005 -May 9, 201417 United States
Unlock Drug Trial Details
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelFACTORIAL
PurposeTREATMENT
Interventions
NameTypeDescription
ORAVESCENT Fentanyl CitrateDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: Patients are included in the study if all of the following criteria are met: * The patient is willing to provide written informed consent to participate in this study. * The patient is 18 through 80 years of age. * Women must be surgically sterile, 2 years postmenopausal, or, i...

Countries:United States
Unlock Eligibility Criteria