Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy

Key Inclusion Criteria:

1. Requirement for a primary unilateral bunionectomy

2. Has an American Society of Anesthesiologists Physical Status of I, II, or III.

3. Pain Intensity (PI) using a Numeric Rating Scale (NRS-R) ≥4 at any given timepointduring the 9 hours after removal of the popliteal sciatic block

4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e.,none, mild, moderate, severe) during the 9 hours after removal of the poplitealsciatic block

5. Able to understand and complete the study requirements (including literacy, toenable diary and questionnaire completion), provide written informed consent, andagree to abide by the study protocol and its restrictions.

Key Exclusion Criteria:

1. Previously dosed with this formulation of MR-107A-02.

2. Subjects with a contralateral foot bunionectomy in the past 6 months.

3. Subject has a concurrent acute or chronic painful physical/restrictive conditionexpected to require analgesic treatment in the postoperative period for pain that isnot strictly related to the bunionectomy, and which may confound the postoperativeassessments.

4. Known hypersensitivity to aspirin, NSAIDs or other medication used in the study.

5. Body mass index (BMI) >40 kg/m2 at screening.

6. Body weight of <43 kg at screening.

7. History of GI bleeding or peptic ulcer disease.

8. Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerativecolitis.

9. A history of bleeding disorders that may affect coagulation.

10. Subjects with prior stroke or transient ischemic attack in the past 12 months priorto screening.