Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Liposome bupivacaine
Liposome bupivacaine+ bupivacaine · 2 trials · 2 indications
Pain rating (NRS) at rest and with movement
Modified BRIEF Pain Inventory (Q1)
| Arm | Type | Description |
|---|---|---|
| Single mixture LB & bupivacaine | EXPERIMENTAL | A single mixture of liposome bupivacaine 1.3% (5 mL) + bupivacaine 0.5% (2.5 mL) injected into the median and ulnar nerves |
| Bupivacaine alone | ACTIVE_COMPARATOR | Bupivacaine 0.5% (7.5 mL) injected into the median and ulnar nerves |
| General anesthesia | SHAM_COMPARATOR | General anesthesia |
| Name | Type | Description |
|---|---|---|
| Liposome bupivacaine + bupivacaine | DRUG | - |
| Liposome bupivacaine | DRUG | - |
Inclusion Criteria: * Male or female, at least 18 years and max 85 years of age at screening * Scheduled to undergo Dupuytren's contracture release * American Society of Anesthesiologists (ASA) physical status I, II or III * Able to demonstrate sensory function by exhibiting sensitivity to cold, pi...
Liposome bupivacaine + bupivacaine has been studied in Phase 2 clinical trials for two hand and foot surgical conditions: Dupuytren's contracture of the hand, also called Viking's disease, and hallux valgus, commonly known as bunions. It is being developed by Pacira BioSciences, Inc. (ticker PCRX).
Pacira BioSciences, Inc., which trades under the ticker PCRX, is the developer of liposome bupivacaine + bupivacaine. The company has sponsored Phase 2 clinical research on the agent in surgical settings involving the hand and foot.
Liposome bupivacaine + bupivacaine is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 program includes completed trials in patients undergoing hand and foot procedures, with enrollment of 40 and 32 participants respectively.
Two completed Phase 2 trials have evaluated liposome bupivacaine + bupivacaine. NCT03106545, titled Liposome Bupivacaine for ANKLE Blocks, enrolled 40 patients with hallux valgus in Belgium. NCT03106519, titled Liposome Bupivacaine for WRIST Blocks, enrolled 32 patients with Dupuytren's contracture of the hand, also in Belgium.
Yes. Liposome bupivacaine + bupivacaine is also known as liposome bupivacaine. Both names refer to the same investigational product developed by Pacira BioSciences, Inc. (PCRX) for use in hand and foot surgical procedures.
The Phase 2 trials of liposome bupivacaine + bupivacaine were randomized, double-blind, and active-controlled. NCT03106545 enrolled 40 patients with hallux valgus, and NCT03106519 enrolled 32 patients with Dupuytren's contracture of the hand. Both studies were conducted in Belgium and included adults aged 18 years and older.