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Dexmedetomidine

Phase 3

Sedation | Small molecule | Pain |Pfizer, Inc.|Last Updated: Mar 22, 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-BlindCONTROLLEDDMCBiomarker
Total Trials5
Total Enrollment415
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01438957Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without IntubationPHASE3 COMPLETED 119 — — Jun 3, 2011Nov 18, 2011Mar 22, 202112 Japan
NCT00875550Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) SubjectsPHASE3 COMPLETED 175 — — Jan 1, 2010Jan 1, 2011Aug 14, 201537 United States, Canada
NCT00526760Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU SubjectsPHASE3 COMPLETED 80 — — Oct 1, 2007Jun 1, 2008Jun 30, 201510 Japan
NCT01378988Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 MonthsPHASE2 COMPLETED 5 — — Jun 1, 2011Aug 1, 2011Jul 24, 20151 United States
NCT01159262Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational AgePHASE2 COMPLETED 36 — — Jul 1, 2010Aug 1, 2011Aug 13, 201518 United States, Guatemala
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Study Endpoints
Primary Endpoints
Percentage of Patients Who Did Not Require Rescue Administration of Propofol to Achieve and Maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 During the Study Drug Administration.
Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated.
6 to 24 hours

Clinical Score Level of Sedation 0 Awake/Alert 1. Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2. Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3. Deeply sedated: Deep sleep, arousable only with significant physical stimulation. 4. Unarousable

Incidence rate of adverse drug reactions of hypotension, hypertension and bradycardia which correspond to the protocol definitions
Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.

Definition: * Hypotension: dosing start or dose increase of vasopressor drug or use of fluid bolus ≥500 mL within 1 hour resulting from SBP\<60mmHg, DBP\<40mmHg or ≥50% lower than baseline. * Hypertension: dosing start or dose increase of intravenous anti-hypertensive medication resulting from SBP\>160, DBP\>100 or. ≥50% higher than baseline. * Bradycardia: dosing start or dose increase of positive chronotropic medication or use of pacemaker resulting from heart rate \<40bpm or ≥50% lower than baseline.

Area Under the Plasma Concentration-time Curve (AUC0-∞)
30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI

Area under the plasma concentration-time curve of dexmedetomidine at 0 to Infinity hours

Observed Peak Plasma Concentration (Cmax)
30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI

Maximum observed concentration of dexmedetomidine in plasma

Steady State Concentration (Css)
30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI

Concentration of dexmedetomidine at steady state in plasma

Terminal Elimination Half-life (t1/2)
30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI

Terminal elimination half-life of dexmedetomidine. Half-life is the time required for plasma concentration of the drug to decrease by 50%.

Time to Reach Maximum Plasma Concentration (Tmax)
30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI

Observed time to reach maximum plasma concentration of dexmedetomidine, expressed in hours

Weight-Adjusted Plasma Clearance (CLw)
30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI

Weight-Adjusted Plasma Clearance of dexmedetomidine after intravenous administration.

Plasma Clearance (CL)
30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI

Clearance of dexmedetomidine after intravenous administration. Clearance is the rate at which the drug is removed from the plasma after the dose.

Volume of Distribution (Vd)
30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI

Volume of distribution of dexmedetomidine after intravenous administration. Volume of distribution measures how much the drug spreads through the body after the dose.

Weight-Adjusted Volume of Distribution (Vdw)
30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI

Weight-Adjusted Volume of distribution of dexmedetomidine after intravenous administration.

Average Total Faces, Legs, Activity, Cry, and Consolability (FLACC) Score
Prior to loading dose and every hour during the maintenance infusion; within 5 minutes after any fentanyl administration during DEX infusion or every 4 hours in case of continuous fentanyl infusion; within 5 minutes prior and after titration of fentanyl

FLACC scale is a 5 category observational measure to assess pediatric pain on face, legs, activity, cry and consolability. Responses in each category are scored between 0 to 2 (0 = normal, relaxed to 2 = upset, rigid), for a maximum total score of 10.

Absolute Time That Subject is in UMSS Range 2-4 During Treatment Period
During the treatment (6 to 24 hours)

The level of sedation will be assessed using the University of Michigan Sedation Scale (UMSS). Score 0 (awake/alert); Score 1 (sleepy/responds appropriately); Score 2 (somnolent/arouses to light stimuli); Score 3 (deep sleep/arouses to deeper physical stimuli); Score 4 (unarousable). The UMSS scores obtained just prior the loading dose (LD) and 5 and 10 minutes during LD; 0, 5, 10, 15, 30, and 60 minutes and thereafter every 4 hours of the maintenance infusion; within 5 minutes of obtaining each pharmacokinetic sample; within 5 minutes prior and after any midazolam rescue during dexmedetomidine infusion period.

Number of Subjects Who Received Rescue Medication for Sedation and Analgesic
During the treatment (6 to 24 hours)

Participants who received rescue medication midazolam for sedation and/or fentanyl for analgesic during study drug Infusion

Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion
During study drug administration (6 to 24 hours)
Secondary Endpoints
Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
15 minutes after the start of study drug, if the OAA/S score is 5.
Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
15 minutes after the start of study drug, if the OAA/S score is 5.
Time to First Rescue Administration of Propofol
During the study drug infusion period (≥15 minutes [Approximate])
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORDexmedetomidine 0 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0 mcg/kg/hr Maintenance dose
Dexmedetomidine 0.067 mcg/kgEXPERIMENTALDexmedetomidine 0.4 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose
Dexmedetomidine 0.25 mcg/kgEXPERIMENTALDexmedetomidine 1.5 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose
Dexmedetomidine 0.5 mcg/kgEXPERIMENTALDexmedetomidine 3 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose
Dexmedetomidine 1.0 mcg/kgEXPERIMENTALDexmedetomidine 6 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose
Dexmedetomidine Low DoseACTIVE_COMPARATOR -
Dexmedetomidine High doseACTIVE_COMPARATOR -
DexmedetomidineEXPERIMENTAL -
Dose level 1EXPERIMENTALDexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
Dose level 2EXPERIMENTALDexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
Dexmedetomidine 0.05 mcg/kgEXPERIMENTALDexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.
Dexmedetomidine 0.1 mcg/kgEXPERIMENTALDexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.
Dexmedetomidine 0.2 mcg/kgEXPERIMENTALDexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Interventions
NameTypeDescription
Dexmedetomidine hydrochlorideDRUGDexmedetomidine 0.2 to 0.7 mcg/kg/hr
PlaceboDRUG -
DexmedetomidineDRUGStudy drug titrated up or down to maintain target UMSS range.
MidazolamDRUGRescue medication for sedation according to UMSS scores
FentanylDRUGRescue medication for pain based on UMSS scores
MorphineDRUGRescue medication for pain based on UMSS scores.
Fentanyl/MorphineDRUGPer package insert, N-PASS scores and investigator discretion.
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: 1. Patient has signed and dated the Informed Consent after the study had been fully explained. 2. Patient is male or female, at least 20 years of age when the Informed Consent is obtained. 3. American Society for Anesthesiologists (ASA) I to III Class. 4. Patient who requires se...

Countries:JapanUnited StatesCanadaGuatemala
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Competitive Landscape -Anesthesia and Sedation 4 trials
CompanyTickerTrialsLead PhaseDrugs
Masimo CorporationMASI1PHASE1Diprivan , Astra-Zeneca
Cardinal Health, Inc.CAH1 — Undisclosed
Medtronic PlcMDT1NAUndisclosed
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