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ARRY-371797, p38 inhibitor;

Phase 2

Dental Pain | Small molecule | Pain |Pfizer, Inc.|Last Updated: Feb 21, 2021

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment353
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00663767A Study of ARRY-371797 in Subjects Undergoing Third Molar ExtractionPHASE2 COMPLETED 250 — — Apr 7, 2008Jun 20, 2008Feb 9, 20212 United States
NCT00542035A Study of ARRY-371797 in Subjects Undergoing Third Molar ExtractionPHASE2 COMPLETED 103 — — Nov 11, 2007Feb 11, 2008Feb 21, 20212 United States
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Study Endpoints
Primary Endpoints
Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR).
6 hours post-dose
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Duration of study
Assess the efficacy of the study drug dosed either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS).
6 hours post dose 2
Secondary Endpoints
Assess the efficacy of the study drug (versus placebo and celecoxib) in terms of pain relief measurements [including TOTPAR, total pain intensity (TPI) and time to rescue medication].
Duration of study
Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS).
Duration of study
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
Placebo, ARRY-371797EXPERIMENTAL -
ARRY-371797, PlaceboEXPERIMENTAL -
ARRY-371797EXPERIMENTAL -
Celecoxib, PlaceboACTIVE_COMPARATOR -
Celecoxib, ARRY-371797EXPERIMENTAL -
Interventions
NameTypeDescription
Placebo; oralDRUGdose 1, dose 2
ARRY-371797, p38 inhibitor; oralDRUGdose 1: multiple dose levels
Celecoxib, COX-2 inhibitor; oralDRUGdose 1
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria: * Scheduled for outpatient oral surgical procedure to remove 3 or more third molars, at least 1 of which is mandibular and fully or partially impacted by bone. * Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days pri...

Countries:United States
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Competitive Landscape -Dental and Oral Health 15 trials
CompanyTickerTrialsLead PhaseDrugs
Haleon PLC Sponsored ADRHLN2NATest Dentifrice, Parodontax Complete Protection, Colgate Cavity Protection
Align Technology, Inc.ALGN2NAUndisclosed
Solventum CorporationSOLV1NAUndisclosed
DENTSPLY SIRONA, Inc.XRAY1NAUndisclosed
Envista Holdings Corp.NVST2 — Undisclosed
Smith & Nephew plc Sponsored ADRSNN1 — Undisclosed
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