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

Main Inclusion Criteria:

1. Requirement for unilateral open inguinal herniorrhaphy with mesh under generalanesthesia.

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

3. Pain Intensity (PI) using NRS-R ≥4 at any given timepoint during the 5 hoursfollowing end of surgery in the eligibility assessment as well as in the baselineassessment (NRS-R and NRS-A) immediately pre-dosing.

4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e.,none, mild, moderate, severe) during the 5 hours following end of surgery.

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.

Main Exclusion Criteria:

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

2. Had any prior inguinal hernia repair in the past 24 months.

3. Has a planned concurrent surgical procedure (e.g., bilateral herniorrhaphy).

4. Has a pre-existing concurrent acute or chronic painful physical/restrictivecondition expected to require analgesic treatment in the postoperative period forpain that is not strictly related to the herniorrhaphy, and which may confound thepostoperative assessments.

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

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

7. Body weight of <43 kg (105.8 lbs) at screening.

8. History of GI bleeding or peptic ulcer disease.

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

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

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