Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery

This is a randomized, double-blind, placebo-controlled, single center study in subjects who have undergone third molar extraction surgery. Eligible subjects will have surgical removal of >2 third molars, of which at least 1 must be a complete or partial mandibular impaction. Each subject's study participation will consist of a screening visit (1-21 days prior to surgery), an inpatient evaluation period of 24 hours following dosing, and a follow-up phone call 3-5 days postdose.

Inclusion criteria

• surgical extraction of > 2 third molars with at least 1 complete or partial mandibular bony extraction

Exclusion criteria

• allergic response to aspirin, NSAIDs, acetaminophen or hydrocodone
• use of aspirin or other analgesics within 48 hours prior to surgery
• current or recent history of drug or alcohol abuse
• any medication for treatment of chronic pain
• clinically significant abnormality on screening laboratory test active or recent history of peptic ulcer disease or GI bleeding
• prior abdominal surgery, except uncomplicated appendectomy
• any other surgical procedure within 30 days before administration of study drug
• pregnancy or breastfeeding
• untreated hypertension; SBP > 140 mmHg or DBP > 95 mmHg