Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HTX-011B · 1 trial · 1 indication
The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2\*PI4+2\*PI6+2\*PI8+2\*PI10+2\*PI12+2\*PI14+4\*PI18+6\*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).
| Arm | Type | Description |
|---|---|---|
| Part A, Cohort A: HTX-011A | EXPERIMENTAL | HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection |
| Parts A and B, Cohort B: Saline Placebo | PLACEBO_COMPARATOR | Saline placebo via injection |
| Part A, Cohort C: HTX-011B | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection |
| Part A, Cohort D: HTX-011B | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection |
| Part A, Cohort E: HTX-011B | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination |
| Part A, Cohort F: HTX-011B | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection |
| Part B, Cohort A: HTX-002 | EXPERIMENTAL | HTX-002, 400 mg via combination |
| Part C, Cohort A: HTX-011B | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation |
| Part C, Cohort B: HTX-011B | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination |
| Part C, Cohort C: HTX-011B | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination |
| Part C, Cohort D: Bupivacaine HCI | ACTIVE_COMPARATOR | Bupivacaine HCl, 100 mg via injection |
| Part C, Cohort E: Saline Placebo | PLACEBO_COMPARATOR | Saline placebo via injection |
| Name | Type | Description |
|---|---|---|
| HTX-011B | DRUG | HTX- 011B (bupivacaine/meloxicam) via injection |
| Placebo | DRUG | Saline placebo via injection |
| HTX-011A | DRUG | HTX- 011A (bupivacaine/meloxicam) via injection |
| HTX-002 | DRUG | HTX-002 via combination |
| Bupivicaine HCl | DRUG | Bupivacaine HCl via injection |
Inclusion Criteria: Subjects must meet all of the following criteria to be considered eligible to participate in the study: 1. Be scheduled to undergo abdominoplasty surgery that is amenable to treatment with a long acting local anesthetic as per the anesthesia protocol 2. Be American Society of A...
HTX-011B is an investigational small molecule being developed for postoperative pain. It is designed to provide analgesia following surgical procedures. The drug is currently in clinical development and has not been approved by regulatory authorities.
HTX-011B is being developed by Heron Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HRTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy for postoperative pain management.
HTX-011B is in Phase 2 clinical development. A Phase 2 trial has been completed to evaluate the drug for postoperative analgesia. The drug remains investigational and has not received regulatory approval.
HTX-011B has been studied in a completed Phase 2 clinical trial registered as NCT02689258. This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of HTX-011 for postoperative analgesia following abdominoplasty surgery in 277 participants in the United States.
HTX-011B is related to HTX-011, which was the subject of the completed Phase 2 clinical trial. The trial evaluated HTX-011 for postoperative pain, and HTX-011B is the drug candidate being developed by Heron Therapeutics for the same indication.