Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain

Inclusion criteria

• Is able to speak and understand the language in which the study is being conducted, is able to understand and comply with the procedures and study requirements, and has voluntarily signed and dated an informed consent form approved by an Institutional Review Board before the conduct of any study procedure.
• Is a male or female ≥18 and ≤65 years of age.
• Scheduled for elective bunionectomy, breast augmentation (in women only), or abdominoplasty.
• Is classified using the American Society of Anesthesiologists Physical Status Classification System as P1 to P2.
• If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing one of the following medically acceptable methods of birth control:
• Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before study drug administration;
• Total abstinence from sexual intercourse since the last menses before study drug administration;
• Intrauterine device; OR
• Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).
• Has a body weight ≥45 kilograms (kg) and a body mass index (BMI) ≤40 kg/m^2.
• Is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete evaluations and diary, remain at the study site for ≥72 hours, and return for follow up Day 8 + 2 days after surgery.

Exclusion criteria

• Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any nonsteroidal anti-inflammatory drugs (NSAIDs); history of NSAID-induced bronchospasm (participants with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to sulfa (including sulfonamide) medicines, ingredients of the study drug, or any other drugs used in the study, including anesthetics and antibiotics that may be required on the day of surgery.
• Has experienced any surgical complications or other issues that, in the investigator's opinion, could compromise the participant's safety if he or she continues into randomized treatment or could confound the results of the study.
• Has a known or suspected history of alcoholism or drug abuse or misuse within 2 years of Screening or evidence of opioid tolerance or physical dependence before dosing with the study drug.
• Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease, or any other condition that, in the investigator's opinion, could compromise the participant's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
• Has long QT Syndrome, a family history of long QT Syndrome, or is taking Class IA or Class III antiarrhythmic medications
• Has a history or current diagnosis of a significant psychiatric disorder that, in the investigator's opinion, would affect the participant's ability to comply with the study requirements.
• Has tested positive either on the urine drug screen or on the alcohol Breathalyzer test. Participants who test positive at Screening only and can produce a prescription in their name from their physician for the medication producing the positive test may be considered for study enrollment at the investigator's discretion. However, they must test negative on the day of the surgery.
• Has a history of a clinically significant (in the investigator's opinion) gastrointestinal (GI) event within 6 months before Screening or has any history of peptic or gastric ulcers or GI bleeding.
• Has an active infection, mucositis, cold sores, viral lesions, local irritation, or