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Also known as POSIMIR® bupivacaine solution
SABER-Bupivacaine Treatment 1a · 2 trials · 1 indication
Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. 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 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.
Cumulative IV morphine-equivalent dose of opioid rescue medication
| Arm | Type | Description |
|---|---|---|
| SABER-Bupivacaine Treatment 1a | EXPERIMENTAL | double-blind |
| Placebo SABER-Bupivacaine Treatment 1b | PLACEBO_COMPARATOR | double-blind |
| Bupivacaine HCl Treatment 1c | ACTIVE_COMPARATOR | double-blind |
| SABER-Bupivacaine Treatment 2a | EXPERIMENTAL | double-blind |
| Placebo SABER-Bupivacaine Treatment 2b | PLACEBO_COMPARATOR | double-blind |
| Bupivacaine HCl Treatment 2c | ACTIVE_COMPARATOR | double-blind |
| Name | Type | Description |
|---|---|---|
| SABER-Bupivacaine Treatment 1a | DRUG | 5.0 ml |
| Placebo SABER-Bupivacaine Treatment 1b | DRUG | 5.0 ml |
| Bupivacaine HCl Treatment 1c | DRUG | 40 ml |
| SABER-Bupivacaine Treatment 2a | DRUG | 7.5 ml |
| Placebo SABER-Bupivacaine Treatment 2b | DRUG | 7.5 ml |
| Bupivacaine HCl Treatment 2c | DRUG | 40 ml |
Inclusion Criteria: * A planned elective, abdominal hysterectomy * Patients suitable for general anaesthesia Exclusion Criteria: * Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities *...
SABER-Bupivacaine Treatment 1a is an investigational small molecule developed by DURECT Corporation for postoperative pain control. It is a formulation of bupivacaine, a local anesthetic, designed to provide extended pain relief after surgery. It has been studied in Phase 2 clinical trials in patients undergoing arthroscopic shoulder surgery and hysterectomy.
SABER-Bupivacaine Treatment 1a is being developed for postoperative pain control. Clinical trials have evaluated it in patients following arthroscopic shoulder surgery and in patients undergoing hysterectomy. It is intended to manage pain after surgical procedures.
SABER-Bupivacaine Treatment 1a targets SCN4A, a voltage-gated sodium channel. It acts as a blocker of this channel. Bupivacaine, the active agent, blocks sodium channels to inhibit nerve signal conduction, which produces local anesthesia and pain relief.
SABER-Bupivacaine Treatment 1a is developed by DURECT Corporation, which trades under the ticker DRRX. DURECT is the sponsor of the clinical trials evaluating this asset for postoperative pain.
SABER-Bupivacaine Treatment 1a is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Two Phase 2 trials have been completed, and no trials are currently active.
SABER-Bupivacaine Treatment 1a has been studied in two completed Phase 2 trials. NCT00993798 evaluated it for postoperative pain after arthroscopic shoulder surgery in 107 patients. NCT00993226 evaluated it for postoperative pain after hysterectomy in 115 patients. Both were randomized, double-blind, and placebo-controlled.