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ACTIQ

Phase 3

Breakthrough Pain | Small molecule | Pain |Teva Pharmaceutical Industries Limited|Last Updated: Jan 29, 2013

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00236145Evaluate the Efficacy and Safety of ACTIQ in Patients With Cancer and Breakthrough PainPHASE3 COMPLETED -Jun 1, 2004 -Jan 29, 2013 -
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Study Endpoints
Primary Endpoints
to determine if ACTIQ treatment will reduce the number of inadequately managed episodes of breakthrough pain
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
ACTIQ (Oral transmucosal fentanyl citrate)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: Patients are included in the study if all of the following criteria are met: * the patient is at least 18 years old * women must be surgically sterile, 2 years postmenopausal, or if of child-bearing potential, must use a medically accepted method of birth control (ie, barrier me...

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