Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for postoperative pain. It is a long-acting local anesthetic intended to provide pain control after surgery. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
SABER-Bupivacaine Treatment 1a is being developed by DURECT Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol DRRX. The company is conducting clinical trials to evaluate the drug's efficacy and safety for postoperative pain management.
SABER-Bupivacaine Treatment 1a is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Two Phase 2 trials have been completed, but the drug remains in active clinical investigation.
SABER-Bupivacaine Treatment 1a has been studied in two completed Phase 2 trials. NCT00993226 evaluated the drug in 115 women undergoing hysterectomy, and NCT00993798 evaluated it in 107 patients following arthroscopic shoulder surgery. Both trials were randomized, double-blind, and placebo-controlled.
SABER-Bupivacaine Treatment 1a is a small molecule that delivers bupivacaine, a local anesthetic, using a sustained-release formulation. It is designed to provide prolonged pain relief at the surgical site. The drug targets pain signaling by blocking nerve impulses in the area where it is administered.