Evaluation of EXPAREL for Prolonged Postsurgical Analgesia in Subjects Undergoing Third Molar Extraction

Inclusion Criteria:

1. Male or female, ≥18 years of age at screening.
2. Scheduled to undergo bilateral third molar extractions (i.e., extraction of all fourthird molars) under local anesthesia. At least one lower mandibular third molar mustinvolve full or partial bony impaction confirmed by visual or radiological evidence.
3. American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
4. Female subjects must be either surgically sterile, using a medically acceptable methodof birth control, or at least 2 years postmenopausal, and must have a documentednegative pregnancy test result during screening and on Day 1 prior to surgery.
5. Able to provide informed consent, adhere to the study visit schedule, and complete allstudy assessments.

Exclusion Criteria:

1. History of hypersensitivity or idiosyncratic reaction to amide-type local anestheticsor opioids.
2. Contraindication to lidocaine, epinephrine, bupivacaine, or oxycodone.
3. History of significant drug allergy (e.g., anaphylaxis or hepatotoxicity).
4. Positive test result from the urine drug screen at screening or prior to the surgicalprocedure.
5. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
6. History or active psychiatric illness (including major depression, bipolar disorder,or anxiety); Type 1 or Type 2 diabetes; severe renal or hepatic impairment;significant cardiovascular disease (including cardiac rhythm disturbance); migraineheadaches, frequent headaches, other pain conditions, or other medical condition that,in the opinion of the Investigator, may increase the risk of surgery or interfere withthe evaluation of the study drug.
7. History of infection requiring intravenous (IV) antibiotics within 45 days or oral (PO) antibiotics within 30 days prior to study drug administration for reasons otherthan dental prophylaxis. Subjects must be afebrile, without signs or symptomsindicative of active infection.
8. Use of any of the following medications within the times specified before surgery:long-acting opioid medication, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin (except for low-dose aspirin used for cardioprotection), or acetaminophen within 3days, or any opioid medication within 24 hours.
9. Initiation of treatment with any of the following medications within 1 month ofEXPAREL infiltration or if the medication(s) are being given to control pain:selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptakeinhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If asubject is taking one of these medications for a reason other than pain control, he orshe must be on a stable dose for at least 1 month prior to EXPAREL administration.
10. Current use of systemic glucocorticosteroids within 1 month of enrollment in thisstudy.
11. Use of any concurrent therapy that could interfere with the evaluation of efficacy orsafety, such as any drugs which in the Investigator's opinion may exert significantanalgesic properties or act synergistically with the investigational product.
12. Administration of an investigational drug within 30 days or 5 elimination half-livesof such investigational drug, whichever is longer, prior to study drug administration,or planned administration of another investigational product or procedure during thesubject's participation in this study.