- Oral surgical procedure having removed 2 third molars (unilateral).
- Pre-dose pain intensity score (100 mm Visual Analog Scale [VAS]) >50 mm within 5 hours
of oral surgery.
- Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.
- Presence or history of any significant hepatic, renal, endocrine, cardiovascular,
neurological (including subjects with a history of frequent moderate to severe
headaches or subjects with episodic migraines more than twice per month), psychiatric,
gastrointestinal, pulmonary, hematologic, or metabolic disorder.
- Prior use of any type of analgesic or NSAID within five half-lives of that drug or
less before taking the first dose of study medication, except for anesthesia for the
- Recent history of chronic analgesic or tranquilizer dependency.
- Active dental infection at the time of surgery.
- Any significant oral surgery complication at the time of surgery or in the immediate
postoperative period or dental surgery lasting > 30 minutes.
- Subjects who are smokers.