Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HTX-034 low dose · 1 trial · 2 indications
The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) of pain intensity scores with activity (windowed worst observation carried forward) through 72 hours. The NRS was an 11-point scale (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
| Arm | Type | Description |
|---|---|---|
| Phase 1b: HTX-034 Low Dose | EXPERIMENTAL | Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses). |
| Phase 1b: HTX-034 High Dose | EXPERIMENTAL | Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses). |
| Phase 2: HTX-034 Low Dose | EXPERIMENTAL | Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses). |
| Phase 2: HTX-034 High Dose | EXPERIMENTAL | Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses). |
| Phase 1b/2: Bupivacaine HCl | ACTIVE_COMPARATOR | Bupivacaine HCl (without epinephrine) 0.5%: 50 mg |
| Name | Type | Description |
|---|---|---|
| HTX-034 low dose | DRUG | HTX-034 (bupivacaine/aprepitant/meloxicam) fixed dose: 21.7 mg/4.3 mg/0.6 mg |
| HTX-034 high dose | DRUG | HTX-034 (bupivacaine/aprepitant/meloxicam) individualized dose: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg |
| Luer lock applicator | DEVICE | Applicator for instillation |
| Bupivacaine HCl | DRUG | Bupivacaine HCl 50 mg |
Inclusion Criteria: * Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia). * Has an American Society of Anesthesiologists (ASA) Physi...
HTX-034 low dose is being studied for pain following bunion surgery, a condition known as postoperative pain after bunionectomy. It is an investigational small molecule developed by Heron Therapeutics, Inc. for musculoskeletal use. The program has completed a Phase 1 trial in adults with bunions and postoperative pain.
HTX-034 low dose is being developed by Heron Therapeutics, Inc., which trades on the Nasdaq under the ticker HRTX. The company is the sponsor of the clinical program evaluating this low dose of HTX-034 in patients undergoing bunionectomy.
HTX-034 low dose is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, active-controlled dose-escalation trial in patients with bunions and postoperative pain.
HTX-034 low dose has been evaluated in one completed Phase 1 trial, NCT04398329, titled Dose-Escalation Study of HTX-034 Following Bunionectomy. The trial enrolled 78 adults aged 18 years and older in the United States and used a randomized, double-blind, active-controlled design.
HTX-034 low dose is not approved. It is an investigational small molecule still in clinical development, with only a completed Phase 1 trial. Heron Therapeutics, Inc. has not announced regulatory approval for this asset for bunions or postoperative pain.