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PF-00345439

Phase 3

Pain | Small molecule | Pain |Cassava Sciences, Inc.|Last Updated: Sep 11, 2015

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment823
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01559701Long-term Safety of PF-00345439 (Oxycodone)PHASE3 COMPLETED 823 — — Apr 1, 2006Feb 1, 2008Sep 11, 2015 - —
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Study Endpoints
Primary Endpoints
Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
12 months
Secondary Endpoints
Percent change from baseline Pain Intensity Scale
baseline 1, 3, 6, 9 and 12 months
Quality of Analgesia - patient reported outcome of analgesia quality using ratings of excellent, very good, good, fair, or poor.
1, 3, 6, 9 and 12 months
Global Assessment of Study Medication - patient reported outcome using ratings of excellent, very good, good, fair, or poor.
1, 3, 6, 9 and 12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-00345439 (oxycodone)EXPERIMENTALPF-00345439 (oxycodone)
Interventions
NameTypeDescription
PF-00345439DRUG5-80 mg twice-a-day for 12 months
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males and females who are ≥ 18 and ≤ 75 years of age with moderate to severe pain in one or more hip or knee joint(s) caused by osteoarthritis for at least three months prior to the Baseline Visit or persistent moderate to severe low back pain for at least six months while reg...

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