A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV

Inclusion Criteria: * Informed consent: Signed informed consent form obtained at screening prior to any procedures being performed. * Gender: Male or non-pregnant and non-lactating female. * Age: 18 years or older at time of consent. * Foot condition: Primary unilateral first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. * Pain Severity: Presence of moderate or severe pain on a categorical pain intensity scale at Baseline * Pain Confirmation: On the 0-10 numerical pain intensity scale at Baseline. * Diary Completion: Be willing and able to record safety and efficacy ratings in the Diaries. * Safe Transportation Home: Patient must have arrangements for transportation home from the research center accompanied by a responsible adult. Exclusion Criteria: * Medical condition: Presence of a serious medical condition, intolerance to NSAIDs, or any other medical condition which, in the opinion of the Investigator, makes the patient unsuitable for participation. * Infection: Acute infection of the surgical site at the time of surgery that could confound post-surgical evaluation. * Drug Allergy: History of hypersensitivity to an opioid drug (such as hydrocodone), promethazine, acetaminophen, NSAID (such as ibuprofen or aspirin), midazolam, propofol, mepivacaine, ropivacaine or ketorolac. * Confounding and Contraindicated Drugs: Other than protocol-permitted medications administered pre-operatively or during surgery: use within 14 days before or during the surgical procedure of any systemic corticosteroid or use within 24 hours or during the surgical procedure of any confounding prescription or non-prescription drug or any drug contraindicated with hydrocodone, acetaminophen, or promethazine. \[Note: Antibiotic for endocarditis prophylaxis (except if known to cause nausea) and aspirin (ASA) ≤ 325 mg for cardiovascular prophylaxis are permitted during the study.\] History of consuming more than 2 alcoholic drinks per day every day for the last month or a positive urine test for opiates, benzodiazepines, barbiturates, tetrahydrocannabinol, methamphetamines, cocaine, oxycodone, cotinine at screening or the morning of surgery will exclude the patient from the trial. * Investigational Drug Use: Use of an investigational drug within the past 30 days. * Participated in Study: Previous participation in this study. * Pregnancy, Lactation: Women who are pregnant or lactating. * Compliance: Inability to swallow capsules whole. * Participant relationship: Employee at the research center, employee of the Principal Investigator, Sub-Investigators, or sponsor or relative of the Investigator, Sub-Investigators or research staff who is involved in this study.