Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Liposomal Bupivacaine
Exparel Injectable Product · 3 trials · 6 indications
Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement
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.
Area under the plasma concentration-versus-time curve (AUC)
Maximum plasma concentration
The apparent terminal elimination half-life (t1/2el)
Apparent Clearance (CL/F)
Mean residence time (MRT)
The apparent terminal elimination half-life (t1/2el).
Apparent volume of distribution (Vd).
Time of Cmax (Tmax)
Average duration of sensory block and motor block
Average duration of sensory block and motor block
| Arm | Type | Description |
|---|---|---|
| Exparel Injectable Product | EXPERIMENTAL | Liposomal 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 Hydrochloride | ACTIVE_COMPARATOR | Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30). |
| Cohort 1 - EXPAREL | EXPERIMENTAL | A 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 - EXPAREL | EXPERIMENTAL | A 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 - EXPAREL | EXPERIMENTAL | A total of 10 subjects will be enrolled. Subjects in this cohort will receive 266mg of EXPAREL only |
| Cohort 4 - bupivacaine | ACTIVE_COMPARATOR | A total of 10 subjects will be enrolled. Subjects in this cohort will receive 100mg Bupivacaine only. |
| Name | Type | Description |
|---|---|---|
| Exparel Injectable Product | DRUG | Liposomal 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 Hydrochloride | DRUG | Bupivacaine 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) |
| Bupivacaine | DRUG | 1.3%, 13.3 mg/mL |
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...
Top 11 of 23 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Inclisiran, YMI024 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 4 | PHASE3 | Ziltivekimab |
| Viatris, Inc. | VTRS | 2 | PHASE3 | Selatogrel |
| Alnylam Pharmaceuticals, Inc | ALNY | 1 | PHASE3 | Zilebesiran |
| NewAmsterdam Pharma Company N.V. | NAMS | 1 | PHASE3 | Obicetrapib |
| GE Healthcare Technologies Inc. | GEHC | 3 | PHASE1 | Regadenoson |
| Humacyte, Inc. | HUMA | 1 | PHASE2 | CTEV |
| AstraZeneca PLC | AZN | 1 | - | Tezepelumab |
| Sanofi SA Sponsored ADR | SNY | 2 | - | alirocumab |
| Bayer | BAYRY | 1 | PHASE1 | Nurandociguat |
| Hoffmann-La Roche | RHHBY | 1 | PHASE1 | RO7763505 |
Exparel Injectable Product is a small molecule drug being developed by Pacira BioSciences for use in postsurgical pain management. It has been studied in clinical trials for conditions including coronary artery disease, bunion, and breast augmentation. The drug is administered as an injectable product for local analgesia.
Exparel Injectable Product is developed by Pacira BioSciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol PCRX. The company is conducting clinical research to evaluate the drug's safety and efficacy in various surgical settings.
Exparel Injectable Product is in Phase 1 clinical development. While one completed trial was registered as Phase 3, the overall development program includes Phase 1 studies. The drug is investigational and has not been approved by regulatory authorities for the indications studied.
Exparel Injectable Product has been studied in three completed clinical trials. NCT03270514 compared sternal wound infiltration with liposomal bupivacaine versus bupivacaine hydrochloride in coronary artery disease patients. NCT04002089 evaluated the drug as a sciatic nerve block for bunionectomy. NCT04293809 assessed its use as a pectoral plane block in breast augmentation.
Exparel Injectable Product contains liposomal bupivacaine, a local anesthetic that provides prolonged postsurgical analgesia. The liposomal formulation slowly releases bupivacaine over time, extending the duration of pain relief compared to standard bupivacaine hydrochloride formulations.