Efficacy, Tolerability, Safety, and Pharmacokinetic Study of DFN-15

Inclusion Criteria

• Subjects scheduled to undergo elective bilateral lower (mandibular) third molar extraction under local anesthesia.
• Subjects must be generally healthy, ambulatory, able to understand and willing to comply with study procedures, study restrictions, assessments, and requirements per the discretion of the investigator.
• Subjects must voluntarily sign written informed consent prior to any study-specific procedures.
• Subjects must have a body mass index (BMI) greater than or equal to 19.0 to less than or equal to 35.0

Exclusion Criteria

• History of migraine or frequent headaches, low back pain, or other acute or chronic pain conditions.
• Acute illness or unresolved local infection prior to surgery that can interfere with the conduct of the study.
• Positive results on urine drug screen or alcohol breath test indicative of illicit drug (Cocaine Metabolites, Marijuana (THC), MDMA (Ecstasy) and Phencyclidine) or alcohol abuse at screening and/or prior to extraction procedure.
• Positive results for the following (prescription included): Amphetamines, Barbiturates, Benzodiazepines, Methadone, Methamphetamine, Opiates, Oxycodone, and Tricyclic Antidepressants.
• Frequent use of nicotine-containing products.
• Excessive intake of caffeine-containing foods or beverages within 48 hours prior to surgery.
• Routinely uses pain medication.
• Currently taking any corticosteroid chronically (except for an inhaled steroid for pulmonary disease, and local topical or ophthalmic steroid) or has taken systemic corticosteroids within 4 weeks of the proposed date of surgery.
• Currently taking central nervous system active drugs such as hypnotics, sedatives, monoamine oxidase inhibitors, sympathomimetic amines, benzodiazepines, tricyclic antidepressants, or serotonin norepinephrine reuptake inhibitors, and anticonvulsants for pain.
• Donated blood products or had blood loss greater than 500 mL 30 days prior to Screening or between Screening and surgery.
• Member or relative of study staff or the Sponsor directly involved in the study.
• Previous participation in this study.
• Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30 days prior to the Screening visit.
• Currently receiving or have received within 7 days prior to investigational product administration in the study, any drug (s) that is metabolized by hepatic microsomal enzyme CYP 2D6.
• Clinically significant disease or disorder which may put the subject at risk, influence the results or the subject's ability to participate in the study.