Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as POSIMIR® bupivacaine solution
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...
Top 2 of 26 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE2 | LY4515100 |
| Pfizer Inc. | PFE | 1 | N/A | Palbociclib |
SABER-Bupivacaine is an investigational therapy being developed for the treatment of postoperative pain, also called post operative pain. It is designed to provide extended-release pain relief following surgery. It has been studied in clinical trials involving patients recovering from abdominal surgery, hernia repair, and shoulder surgery.
SABER-Bupivacaine contains bupivacaine, a small molecule that targets SCN4A. It acts as a blocker of this sodium channel, which is involved in pain signaling. The SABER delivery system is designed to release bupivacaine over an extended period, potentially providing longer-lasting local pain relief after surgery compared with standard bupivacaine.
SABER-Bupivacaine is being developed by DURECT Corporation, which trades under the ticker symbol DRRX. DURECT is the company responsible for the SABER-Bupivacaine program, including its clinical development for postoperative pain.
SABER-Bupivacaine is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The program includes completed Phase 2 and Phase 3 trials evaluating its safety and efficacy for postoperative pain.
SABER-Bupivacaine has been studied in completed clinical trials including NCT02574520, a Phase 3 trial in post operative pain; NCT01052012, a Phase 3 trial in postoperative pain after abdominal surgery; NCT00974350, a Phase 2 trial after hernia repair; and NCT00818363, a Phase 2 trial after shoulder surgery.
Yes, SABER-Bupivacaine (Part 1) is an alternative name for SABER-Bupivacaine. Both names refer to the same investigational extended-release bupivacaine product developed by DURECT Corporation for postoperative pain. Searches using either name refer to the same drug candidate.