Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SABER-Bupivacaine (Part 1)
SABER-Bupivacaine · 4 trials · 5 indications
A derived measure computed based on a patient-reported numerical pain rating scale assessing pain as a whole number from 0 (no pain) to 10 (worst pain imaginable) when the subject sits up from a supine position. This measure was evaluated by electronic diary at 13 planned time points from 0 to 48 hours post-treatment. The values reported are mean pain scores for each treatment group.
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.
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. 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 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.
| Arm | Type | Description |
|---|---|---|
| Part 1 | PLACEBO_COMPARATOR | SABER-Bupivacaine and Saline Placebo |
| Part 2 | ACTIVE_COMPARATOR | SABER-Bupivacaine and Bupivacaine HCl |
| Active: SABER-Bupivacaine | EXPERIMENTAL | SABER-Bupivacaine |
| Comparator: Bupivacaine HCl | ACTIVE_COMPARATOR | Bupivacaine HCl |
| Placebo: SABER-Placebo | PLACEBO_COMPARATOR | SABER-Placebo |
| Group 1: SABER-Bupivacaine | EXPERIMENTAL | 5.0 mL SABER-Bupivacaine/Once |
| Group 2: SABER-Placebo | PLACEBO_COMPARATOR | 5.0 mL SABER-Placebo/Once |
| Group 2: SABER-Bupivacaine | EXPERIMENTAL | 5.0 mL SABER-Bupivacaine/Once |
| Group 3: SABER-Placebo | PLACEBO_COMPARATOR | 2.5 mL or 5.0 mL SABER-Placebo/Once |
| Name | Type | Description |
|---|---|---|
| SABER-Bupivacaine (Part 1) | DRUG | 5 ml once at end of surgery |
| SABER-Bupivacaine (Part 2) | DRUG | 5 ml once at end of surgery |
| Saline Placebo | DRUG | 5 ml once at end of surgery |
| Bupivacaine HCl | DRUG | 0.5%, 15 ml, once at end of surgery |
| SABER-Bupivacaine | DRUG | Injectable Extended Release Solution; SABER-Bupivacaine /Once |
| SABER-Placebo | DRUG | Injectable Solution; SABER-Placebo/Once |
Inclusion Criteria: * Patients scheduled for elective outpatient laparoscopic cholecystectomy using a conventional 4-port laparoscopic procedure. * Must be able and willing to provide written informed consent, complete trial-related procedures, and communicate with the trial staff. * Males and fema...
SABER-Bupivacaine is an investigational long-acting formulation of bupivacaine being developed to treat postoperative pain, including pain after abdominal surgery, hernia repair, and shoulder surgery. It is designed to provide extended pain relief after surgery. It is not approved and remains in clinical development.
SABER-Bupivacaine is being developed by DURECT Corporation, which trades on the Nasdaq under the ticker DRRX. DURECT is the sponsor of the clinical program evaluating the asset in postoperative pain. The drug is an investigational product and has not been approved for commercial use.
SABER-Bupivacaine is in Phase 3 clinical development. Its Phase 3 program includes trials such as NCT02574520 and NCT01052012, both completed. Earlier Phase 2 studies, NCT00974350 and NCT00974350, evaluated the drug after hernia repair and shoulder surgery. The drug is investigational and has not been approved.
SABER-Bupivacaine has been studied in completed trials including NCT02574520, a Phase 3 trial in postoperative pain, and NCT01052012, a Phase 3 trial in postoperative pain and abdominal surgery. Phase 2 trials NCT00974350 and NCT00818363 evaluated hernia repair and shoulder surgery pain. All listed trials are completed.
Yes, SABER-Bupivacaine (Part 1) is an alternative name for SABER-Bupivacaine. Both names refer to the same DURECT Corporation investigational product for postoperative pain. The parenthetical designation distinguishes a portion of the clinical program rather than a separate drug asset.
Across the reported SABER-Bupivacaine clinical trials, total enrollment is 515 patients. The studies were randomized, double-blind, and placebo-controlled, and enrolled adults aged 18 years and older. Trials were conducted in the United States, Australia, and New Zealand. The program includes both Phase 2 and Phase 3 studies.