Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HTX-011A · 1 trial · 2 indications
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 |
|---|---|---|
| HTX-011A: 200 mg | EXPERIMENTAL | HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg via injection. |
| HTX-011B: 30 mg | EXPERIMENTAL | HTX 011B (bupivacaine/meloxicam), 30 mg/0.9 mg via injection. |
| HTX-011B : 60 mg | EXPERIMENTAL | HTX-011B (bupivacaine/meloxicam) 60 mg/1.8 mg via injection or instillation. |
| HTX-011B: 120 mg | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 120 mg/3.6 mg via injection or instillation. |
| HTX-011B: 200 mg | EXPERIMENTAL | HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection. |
| Bupivacaine HCI | ACTIVE_COMPARATOR | Bupivacaine HCI, 50 mg via injection. |
| Saline Placebo | ACTIVE_COMPARATOR | Saline placebo via injection. |
| HTX-002, 60 mg | EXPERIMENTAL | HTX- 002, 60 mg via injection. |
| HTX-002, 120 mg | EXPERIMENTAL | HTX-002, 120 mg via injection. |
| HTX-002, 200 mg | EXPERIMENTAL | HTX-002, 200 mg via injection. |
| HTX-009 | EXPERIMENTAL | HTX-009, 3.6 mg via injection. |
| Name | Type | Description |
|---|---|---|
| HTX-011A | DRUG | HTX-011A (bupivacaine/meloxicam), via injection. |
| Saline Placebo | BIOLOGICAL | Saline placebo via injection. |
| HTX-011B | DRUG | HTX-011B (bupivacaine/meloxicam), via injection or instillation. |
| HTX-002 | DRUG | HTX-002, via injection. |
| Bupivacaine HCl | DRUG | Bupivacaine HCI, via injection. |
| HTX-009 | DRUG | HTX-009, via injection. |
Inclusion Criteria: 1. Be male or female 18 years of age or older 2. Female subjects are eligible only if all of the following apply: 1. Not pregnant (female subject of child bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before surger...
HTX-011A is an investigational small molecule being developed for postoperative pain. It is designed for local administration to provide analgesia following surgical procedures. In clinical trials, it has been evaluated for pain management after bunionectomy surgery. The drug is still in clinical development and has not been approved by regulatory authorities.
HTX-011A is being developed by Heron Therapeutics, Inc., a biopharmaceutical company. Heron Therapeutics is publicly traded under the ticker symbol HRTX. The company is conducting clinical trials to evaluate the safety and efficacy of HTX-011A for the management of postoperative pain.
HTX-011A is currently in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, active-controlled study. The drug is investigational and has not been approved by the FDA or any other regulatory agency. Further clinical development may be required before it can be considered for approval.
HTX-011A has been studied in one completed Phase 2 clinical trial with the identifier NCT02762929. This trial evaluated the efficacy and safety of locally administered HTX-011 for postoperative analgesia following bunionectomy. The study enrolled 430 participants in the United States and included adults aged 18 years and older.
HTX-011A is related to HTX-011, as the clinical trial for HTX-011A was conducted under the name HTX-011. The trial NCT02762929 evaluated HTX-011 for postoperative analgesia. HTX-011A appears to be an alternative designation for the same investigational drug candidate.