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Methylnaltrexone

Phase 3

Terminal Illness | Small molecule | Other |Bausch Health Companies Inc.|Last Updated: Nov 27, 2019

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
UNCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment116
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01367613Open-Label Treatment Extension of Protocol MNTX 302PHASE3 COMPLETED 89Mar 1, 2004Jan 1, 2006Nov 27, 20191 United States
NCT01367600Open-Label Treatment Extension of Protocol MNTX 301PHASE3 COMPLETED 27Feb 1, 2003Feb 1, 2005Nov 27, 20191 United States
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Study Endpoints
Primary Endpoints
Number of patients with adverse events
3 months

To provide access to treatment with MNTX, administered SC, to patients who completed Progenics' Protocol MNTX 302

Secondary Endpoints
Change from baseline in pain scores
3 months
Number of patients with opioid withdrawal symptoms
3 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Interventions
NameTypeDescription
SC MethylnaltrexoneDRUG -
SC Methylnaltrexone (MNTX)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Must be enrolled and consented within 28 days of the end of study visit of MNTX 302 and 14 or more days from first dose of study drug in MNTX 302. 2. Negative pregnancy test 3. Stable vital signs Exclusion Criteria: 1. Women who are pregnant and/or nursing 2. Received any i...

Countries:United States
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