Analgesic Efficacy and Safety of ADL5859 in Subjects With Acute Dental Pain After Third Molar Extraction

A Randomized, Single-Dose, Double-Blind, Active- and Placebo-Controlled Study of ADL5859 for the Treatment of Pain After Surgical Removal of Impacted Third Molars

The objective of this study is to evaluate the analgesic efficacy and safety of ADL5859 compared with placebo and an active control (ibuprofen) in subjects with acute dental pain after third molar extraction.

Key Inclusion Criteria:

• have 2 or more 3rd molars requiring extraction, including at least 1 partially or completely bone-impacted mandibular molar
• experience moderate to severe pain intensity as measured by the Numeric Pain Rating Scale (NPRS) (score ≥ 5) within 6 hours after surgery
• for male subjects, be surgically sterile or agree to use an appropriate method of contraception or have a sexual partner who is surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive
• for female subjects, be using contraceptives, be postmenopausal, or have undergone hysterectomy or tubal ligation
• be able to take oral study medications

Key Exclusion Criteria:

• have positive results either on the urine screening tests for opiates, tetrahydrocannabinol,cocaine, amphetamines, barbiturates, benzodiazepines, phencyclidine, or propoxyphene or on the alcohol breathalyzer test
• have a history of alcoholism or drug addiction or abuse within 5 years before dosing with study medication
• have a history of chronic use (defined as daily use for > 2 weeks) of glucocorticoids,nonsteroidal anti-inflammatory drugs, or opiates for any condition within 6 months of study medication administration
• have a known allergy or history of significant reaction to any of the known treatment medications (ADL5859-like compounds or ibuprofen) or rescue pain medication (acetaminophen)
• have significant renal or hepatic disease, as indicated by clinical laboratory assessment
• have a known history of epilepsy or seizure disorder, including history of febrile seizure, or any other medical or psychiatric condition that, in the judgment of the investigator, would put the subject at risk while in the study, could influence the results of the study, or could negatively affect the subject's ability to participate in the study
• have a history or evidence of orthostatic hypotension at screening have a history of significant head trauma (head injury with loss of consciousness)