Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 small molecule being developed for postoperative pain, including pain following shoulder surgery, hernia repair, and abdominal surgery. It is designed to provide extended-release pain relief after surgical procedures. The drug is currently in clinical development and has not been approved by the FDA.
SABER-Bupivacaine is being developed by DURECT Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol DRRX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for postoperative pain management.
SABER-Bupivacaine is in Phase 3 clinical development. It has completed Phase 2 and Phase 3 trials, including a Phase 3 study for postoperative pain following abdominal surgery and another Phase 3 trial for pain relief after surgery. The drug remains investigational and is not yet FDA approved.
SABER-Bupivacaine has completed three clinical trials: NCT00818363 (Phase 2, shoulder surgery pain, 60 patients), NCT00974350 (Phase 2, hernia repair pain, 124 patients), and NCT01052012 (Phase 3, abdominal surgery pain, 331 patients). All trials were randomized, double-blind, and placebo-controlled, with a total enrollment of 515 patients.
SABER-Bupivacaine is a small molecule formulation of bupivacaine, a local anesthetic that works by blocking sodium channels on nerve cells, preventing the transmission of pain signals. The extended-release formulation is designed to provide prolonged pain relief after surgery, reducing the need for additional pain medication.