Inclusion Criteria:

• Scheduled for outpatient oral surgical procedure to remove 3 or more third molars, at least 1 of which is mandibular and fully or partially impacted by bone;
• Females of childbearing potential must be willing to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to the dosing of trial medication until the completion of the follow-up procedures;
• A non-clinically significant ECG at screening and prior to surgery on Day 1 with QTc interval ≤ 450 msec for each individual ECG;
• Body weight >50 kg (110 lbs);
• Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance;
• Postsurgical pain rating of "moderate" or "severe" and VAS pain intensity ≥ 50 mm.

Exclusion Criteria:

• Evidence or history of clinically significant dermatologic, hematological, renal, endocrine (e.g. poorly controlled diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, or allergic disease (including clinically significant drug allergies that could impact the conduct of this study, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
• Pregnancy or lactation;
• Positive urine drug screen at the screening visit;
• Use of prohibited prescription drugs, or grapefruit juice within 7 days of randomization; prohibited medications are defined as nonsteroidal and steroidal antiinflammatory drugs, analgesics including opioids (except low dose aspirin for myocardial infarction prophylaxis), P450 CYP3A substrates or inhibitors (strong or moderate).
• Use of P450 CYP3A inducers including St John's Wort within 14 days of randomization.