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

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive Design, Single-Dose Study of Intravenous N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery

To evaluate the safety and efficacy of single IV doses of N1539 after 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