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 an investigational small molecule being developed for the treatment of bunions and postoperative pain. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety and efficacy in patients following bunionectomy procedures.
HTX-034 low dose 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 potential in treating postoperative pain associated with bunionectomy procedures.
HTX-034 low dose is in Phase 1 clinical development. A Phase 1 dose-escalation study has been completed, which enrolled 78 participants in the United States. The drug remains investigational and has not received FDA approval for any indication.
HTX-034 low dose has been studied in one completed Phase 1 clinical trial with the identifier NCT04398329. This was a dose-escalation study conducted in the United States following bunionectomy, enrolling 78 participants aged 18 years and older. The trial was randomized, double-blind, and active-controlled.
HTX-034 low dose is a specific dosage form of the investigational drug HTX-034. The clinical trial NCT04398329 evaluated HTX-034 at various dose levels, including the low dose formulation. Both refer to the same drug candidate being developed by Heron Therapeutics for postoperative pain management.