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Exparel Injectable Product

Phase 3

Coronary Artery Disease | Small molecule | Cardiovascular |Pacira BioSciences, Inc.|Last Updated: Jan 29, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Exparel Injectable Product · 3 trials · 6 indications

Phase 3 1Phase 1 2
NCT03270514Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine HydrochlorideCoronary Artery Disease
COMPLETED60 Analytics
PHASE3COMPLETED
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
Coronary Artery Disease
NCT0327051460
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Study Endpoints

Primary Endpoints

Post-operative Pain Intensity
NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively

Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement

Total Narcotic Consumption
0-72 hours post-operative period

All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups.

Pharmacokinetic 1 (area under the plasma concentration)
predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration

Area under the plasma concentration-versus-time curve (AUC)

Pharmacokinetic 2 (Cmax)
predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration

Maximum plasma concentration

Pharmacokinetic 3 (half-life)
predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration

The apparent terminal elimination half-life (t1/2el)

Pharmacokinetic 4 (apparent clearance)
predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration

Apparent Clearance (CL/F)

Pharmacokinetic 5 (Mean residence time)
predose (up to 15 min before block), 15 min(±10min), 30 min(±5min), and 1(±15min), 2(±15min), 6(±30min), 10(±30min), 18(±1), 26(±1), 36(±2), 48(±2), 60(±2), 72(±3), and 96 (±3) hours from start of study drug administration

Mean residence time (MRT)

Pharmacokinetic 3 (half-life )
predose (up to 15 min before block), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1h), 60(±2h), 72(±2h), 84(±2h), 96(±3h), 120(±3h), 144(±3h), and 168(±3h) hours following block

The apparent terminal elimination half-life (t1/2el).

Pharmacokinetic 5 (volume of distribution)
predose (up to 15 min before block), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1h), 60(±2h), 72(±2h), 84(±2h), 96(±3h), 120(±3h), 144(±3h), and 168(±3h) hours following block

Apparent volume of distribution (Vd).

Pharmacokinetic 6 (Tmax)
predose (up to 15 min before block), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1h), 60(±2h), 72(±2h), 84(±2h), 96(±3h), 120(±3h), 144(±3h), and 168(±3h) hours following block

Time of Cmax (Tmax)

Pharmacodynamic 1 (duration of sensory and motor block)
up to 15 min before block, 15 min(±5 min), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1), 60(±2), 72(±2), 84(±2), 96(±3), 120(±3), 144(±3), and 168(±3) hours following block

Average duration of sensory block and motor block

Pharmacodynamic 2 (duration of sensory and motor block)
up to 15 min before block, 15 min(±5min), 30 min(±5min), 45 min(±5min), and 60 min (±15min) and 30 min(±5min), 45 min(±5min), 1(±15min), 2(±30min), 12(±30min), 24(±1), 60(±2), 72(±2), 84(±2), 96(±3), 120(±3), 144(±3), and 168(±3) hours following block

Average duration of sensory block and motor block

Secondary Endpoints

Time to Extubation
From the end of surgery until the patient is extubated up to 72 hours post-operatively
Patient Time to Mobilization
From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours*
Patient Time to Out of Bed to Chair
From time of end of surgery to time of mobilization up to 72 hours post-operatively
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Exparel Injectable ProductEXPERIMENTALLiposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Bupivacaine HydrochlorideACTIVE_COMPARATORBupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Cohort 1 - EXPARELEXPERIMENTALA total of 15 subjects will be enrolled in this cohort. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of saline
Cohort 2 - EXPARELEXPERIMENTALA total of 15 subjects will be enrolled. Subjects in this cohort will receive 20mL EXPAREL (266mg) with 30mL of 0.5% bupivacaine HCl (150mg)
Cohort 3 - EXPARELEXPERIMENTALA total of 10 subjects will be enrolled. Subjects in this cohort will receive 266mg of EXPAREL only
Cohort 4 - bupivacaineACTIVE_COMPARATORA total of 10 subjects will be enrolled. Subjects in this cohort will receive 100mg Bupivacaine only.

Interventions

NameTypeDescription
Exparel Injectable ProductDRUGLiposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
Bupivacaine HydrochlorideDRUGBupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
BupivacaineDRUG1.3%, 13.3 mg/mL
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass) * Surgery with the use of cardiopulmonary bypass Exclusion Criteria: * Minimally invasiv...

Countries:United States
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Competitive Landscape -Coronary Artery Disease 99 trials

CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO5PHASE3Ziltivekimab
Novartis AG Sponsored ADRNVS4PHASE3Inclisiran
Boston Scientific CorporationBSX8PHASE3Undisclosed
Alnylam Pharmaceuticals, IncALNY1PHASE3Zilebesiran
Viatris, Inc.VTRS1PHASE3Selatogrel
NewAmsterdam Pharma Company N.V.NAMS1PHASE3obicetrapib, ezetimibe daily
GE Healthcare Technologies Inc.GEHC3PHASE1Regadenoson
Abbott LaboratoriesABT13 - Undisclosed
HeartFlow, Inc.HTFL5 - Undisclosed
Medtronic PlcMDT3N/AUndisclosed
Teleflex IncorporatedTFX2N/AUndisclosed
AstraZeneca PLCAZN1 - Tezepelumab
BioCardia, Inc.BCDA1N/AUndisclosed
Orchestra BioMed Holdings, Inc.OBIO1N/AUndisclosed
Sanofi SA Sponsored ADRSNY1 - alirocumab/2week, statin ± ezetimibe
Johnson & JohnsonJNJ1N/AUndisclosed
Rhythm Pharmaceuticals, Inc.RYTM2N/AUndisclosed
Healthcare Services Group, Inc.HCSG1 - Undisclosed
Collegium Pharmaceutical, Inc.COLL1 - Flozin
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Frequently asked questions about Exparel Injectable Product

What is Exparel Injectable Product used for?

Exparel Injectable Product is a small molecule being studied for use in Coronary Artery Disease, Breast Augmentation, and Bunion. It is an investigational drug developed by Pacira BioSciences, Inc. (PCRX) and is currently in Phase 1 clinical development.

Who makes Exparel Injectable Product?

Exparel Injectable Product is developed by Pacira BioSciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker PCRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various surgical and pain management settings.

What phase is Exparel Injectable Product in?

Exparel Injectable Product is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its pharmacokinetics, safety, and potential therapeutic benefits.

What clinical trials is Exparel Injectable Product in?

Exparel Injectable Product has been studied in three completed clinical trials: NCT03270514, a Phase 3 trial in coronary artery disease; NCT04002089, a Phase 1 trial in bunion; and NCT04293809, a Phase 1 trial in breast augmentation. All trials were conducted in the United States.

How does Exparel Injectable Product work?

Exparel Injectable Product is a small molecule that works by providing postsurgical analgesia through local administration. It is designed to deliver prolonged pain relief at the site of injection, as demonstrated in studies evaluating its use as a nerve block for bunionectomy and a pectoral plane block for breast augmentation.