The purpose of this study is to assess the safety of IW-6118 when administered as a single oral dose to patients undergoing third molar extraction. Efficacy will be assessed in an exploratory manner.

Inclusion Criteria:

• Between 18 and 30 years old at time of screening;
• BMI > 18.5 and < 30.0;
• In overall good health with no clinically-significant laboratory, ECG, or physical exam findings;
• Patient requires two ipsilateral third molar extractions of which one must be a full or partial bony mandibular impaction;
• Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception;
• Other inclusion criteria per protocol.

Exclusion Criteria:

• History of any clinically-significant medical condition;
• Previous usage of prescription, OTC, or investigational drugs as per protocol requirements;
• Inadequate levels of pain to be included in the study;
• Other exclusion criteria per protocol.