A Phase 2, Two-Part Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

Exclusion Criteria

• •1. Have a known allergy to Bupivacaine/Meloxicam or any HTX-011/placebo excipient or to any peri- or postoperative medications used in this study including oxycodone lidocaine, propofol, fentanyl, and midazolam.
• •2. Have a clinically significant abnormal clinical laboratory test value according to the judgment of the investigator.
• •3. Have history of or positive test results for HIV or hepatitis B or C at screening.
• •4. Have, as determined by the investigator or the study's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
• •5. Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
• •6. Have another painful physical condition that, in the opinion of the investigator, may confound the assessments of postoperative pain.
• •7. Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of study treatment initiation.
• •8. Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the investigator's opinion may exert significant analgesic properties or act synergistically with HTX-011-19.
• •9. Have evidence of a clinically significant 12-lead ECG abnormality according to the judgment of the investigator.
• •10. Have a history of alcohol abuse (regularly drinks \> 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse.
• •11. Have positive results on the alcohol breath test indicative of alcohol abuse or urine drug screen indicative of illicit drug use (unless results can be explained by a current prescription or acceptable over-the-counter medication at screening as determined by the investigator; however, the urine drug screen at prior to surgery must be negative) at screening, and/or prior to surgery.
• •12. Unable to discontinue medications that have not been at a stable dose for at least 14 days prior to the scheduled bunionectomy procedure, within 5 half-lives of the specific prior medication (or, if half-life is not known, within 48 hours) before dosing with study medication.
• •13. Have utilized corticosteroids, either systemically, inhaled either intranasally or orally, or by intra-articular injection, within 14 days prior to the study surgical procedure.
• •14. Have received any investigational product within 30 days before dosing with study medication.
• •15. Have previously received HTX-011-19 in clinical trials or had bunionectomy in the last 3 months.
• •16. Experiences a clinically significant event during surgery prior to the administration of the investigational product (e.g., excessive bleeding, hemodynamic instability) that would render the subject medically unstable, complicate their postsurgical course, or significantly increase the risk of study drug administration as per the judgment of the investigator.