A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain

Inclusion criteria

• ✓. Able to provide written informed consent prior to any study procedures.
• ✓. Able to communicate clearly with the Investigators and study staff.
• ✓. Males and females aged 18 years or older.
• ✓. Scheduled for elective primary unilateral first metatarsal bunionectomy surgery (osteotomy and internal fixation) with no ancillary procedures.
• ✓. Female subjects must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing doublebarrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than two months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study.
• ✓. Negative alcohol breath/saliva test and urine drug screen for drugs of abuse at Screening and at Baseline. Subjects with positive results on the alcohol breath/saliva test or urine drug screen at Screening, and/or prior to surgery, will not be allowed to proceed in the study unless the results can be explained by a current prescription or acceptable over-the-counter medication as determined by the Investigator. Note that for those subjects who test positive for tetrahydrocannabinol (THC), if they are willing to abstain from use or consumption of THC-containing products from Screening thru last Follow-up Visit, they may be allowed to participate in the study.
• ✓. American Society of Anesthesiologists (ASA) Physical Status of I or II (see Appendix, Section 14.1).
• ✓. Body Mass Index (BMI) ≤35.

Exclusion criteria