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Immediate release morphine

Phase 2

Cancer | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Nov 19, 2020

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04635852Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Cancer PatientsPHASE2 COMPLETED 10Mar 1, 2013Dec 1, 2014Nov 19, 20203 Germany
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Study Endpoints
Primary Endpoints
Time to onset of meaningful breathlessness relief
minutes (by stop watch) from drug application of FBT/IRM up to breathlessness relief

To determine the time to onset of meaningful breathlessness relief of fentanyl buccal tablet (FBT) in comparison to immediate-release morphine (IRM)

Secondary Endpoints
Breathlessness intensity
at 0, 3, 5, 10, 15, 20, 30, 45 and 60 minutes after application of FBT/IRM
Numbers of rescue medication doses
Numbers of rescue medication doses through study completion, assessed at day 10 (final visit)
Patient's & investigator's satisfaction
through study completion, day 10 (e.g. final visit)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FentanylEXPERIMENTALFentanyl buccal tablet Dosage: 100µg - 600 µg Fentanyl (to be determined by titration) Administration: buccal administration (tablet)
Immediate release morphineACTIVE_COMPARATORImmediate release morphine, solution Dosage: Start with a minimum of 5mg (to be determined by titration)
Interventions
NameTypeDescription
FentanylDRUG -
Immediate release morphineDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: 1. Histologically or cytologically proven cancer of any entity which is non-curable as judged by the referring physician or investigator 2. To be an inpatient during the study 3. Refractory breathlessness - this study applies only to 'refractory breathlessness ' and is defined: ...

Countries:Germany
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