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SABER-Bupivacaine

Phase 3

Postoperative Pain | Small molecule | Pain |DURECT Corporation|Last Updated: Jun 1, 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 Trials3
Total Enrollment515
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01052012Bupivacaine Effectiveness and Safety in SABER® TrialPHASE3 COMPLETED 331Dec 1, 2009Sep 1, 2011Jun 1, 202126 United States, Australia +1
NCT00818363A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder SurgeryPHASE2 COMPLETED 60Dec 1, 2008Oct 1, 2009Jun 1, 20219 Australia, New Zealand
NCT00974350A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia RepairPHASE2 COMPLETED 124Jan 1, 2007Oct 1, 2007May 27, 20215 Australia, New Zealand
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Study Endpoints
Primary Endpoints
Mean Pain Intensity on Movement
0 to 72 hours post-dose

Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.

Supplemental Opioid Use
0-72 hours post dose

Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.

Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose.
0 to 72 hours post-dose

Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.

Pain Intensity on Movement
1 to 72 hours post-dose

Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.

Proportion (Percent) of Patients Using Supplemental Opioids
0 to 14 days post-dose
Secondary Endpoints
Mean Pain Intensity on Movement
0 to 48 hours post-dose
Total Morphine-equivalent Dose
0-48 hours post dose
Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
0 to 14 days post-dose (Visits 3 and 4)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active: SABER-BupivacaineEXPERIMENTALSABER-Bupivacaine
Comparator: Bupivacaine HClACTIVE_COMPARATORBupivacaine HCl
Placebo: SABER-PlaceboPLACEBO_COMPARATORSABER-Placebo
Group 1: SABER-BupivacaineEXPERIMENTAL5.0 mL SABER-Bupivacaine/Once
Group 2: SABER-PlaceboPLACEBO_COMPARATOR5.0 mL SABER-Placebo/Once
Group 2: SABER-BupivacaineEXPERIMENTAL5.0 mL SABER-Bupivacaine/Once
Group 3: SABER-PlaceboPLACEBO_COMPARATOR2.5 mL or 5.0 mL SABER-Placebo/Once
Interventions
NameTypeDescription
SABER-BupivacaineDRUGInjectable Extended Release Solution; SABER-Bupivacaine /Once
Bupivacaine HClDRUGInjectable Solution; Bupivacaine HCl /Once
SABER-PlaceboDRUGInjectable Solution; SABER-Placebo/Once
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff * Males and females, 18 years of age and older scheduled to undergo elective general abdominal surgery * Patients mus...

Countries:United StatesAustraliaNew Zealand
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