A Study of MDT-10013 in the Treatment of Acute Postoperative Pain Following Bunionectomy

Inclusion Criteria

• Is male or female aged 18 to 80 years.
• Has a body mass index from 18 kg/m2 to 40 kg/m2.
• Is scheduled to undergo primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
• Is classified by American Society of Anesthesiologists Physical Status Classification System as Class I or II.
• Must meet the following criteria if female:
• Is of non-childbearing potential, defined as any woman who has undergone surgical sterilization or is more than 2 years postmenopausal
• If of childbearing potential, may be enrolled on the condition that results of a pregnancy test are negative at baseline (at Screening and before surgery) and that she is routinely using an effective method of birth control with a low failure rate (i.e., hormonal contraception, intrauterine device, condoms in combination with a spermicidal cream, or total sexual abstinence)
• Has read, understood, and signed the informed consent prior to study entry.
• Is mentally competent, reliable, and cooperative to undergo all visits and procedures scheduled in the study protocol and to record the required information.
• Has medical history, physical examination, vital signs, laboratory tests, and 12-lead electrocardiograms (ECGs) that are normal or without clinically relevant abnormalities as per investigator's judgment.

Exclusion Criteria

• Is a female who is pregnant or breastfeeding.
• Is not indicated for surgery because of an inflammatory process or risk of infection or delayed wound healing (e.g., autoimmune disorder).
• Has a history of allergy or hypersensitivity to the components in the investigational product or to the opioid medication (oxycodone).
• Before surgery, has current orthostatic hypotension (defined as systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg or an increase in heart rate by 20 beats per minute within 3 minutes of sitting up or standing).
• Has severe asthma, defined as requiring frequent or ongoing treatment to control symptoms. Exercise-induced asthma or mild asthma not requiring ongoing treatment may not be exclusionary at the discretion of the investigator.
• Has a current gastrointestinal disorder associated with bleeding, a history of such a disorder, or gastrointestinal inflammatory diseases as Crohn's disease or ulcerative colitis.
• Has any clinically significant cardiovascular condition as evidenced by physical examination, medical history, and/or baseline ECG.
• Has evidence of bradycardia as shown by heart rate of 1.5 times upper limit of normal).
• Has chronic impairment liver function (aspartate aminotransferase or alanine aminotransferase >3 times upper limit of normal).
• Has insulin-dependent diabetes or uncontrolled diabetes mellitus (glycosylated hemoglobin >7%).
• Has leukopenia (<3500 leukocytes/μL).
• Has current treatment with any of the following medications:
• Systemic corticosteroids (intranasal/inhaled steroids are acceptable).
• Immunosuppressant therapy to treat autoimmune diseases (e.g., rheumatoid arthritis, multiple sclerosis, myasthenia gravis, systemic lupus erythematosus, sarcoidosis, focal segmental glomerulosclerosis, Crohn's disease, Behcet's Disease, pemphigus, and ulcerative colitis).
• Oral or topical products that contain clonidine (e.g., Catapres).
• Herbal supplements that contain yohimbine.
• Anticoagulant/antiplatelet therapy (prophylactic aspirin at 81 mg/day is acceptable). If applicable, aspirin therapy should be held before and after the study procedure on the basis of the investigator's discretion.
• Antiepileptic drugs, antipsychotics, tricyclic antidepressants, monoamine oxidase inhibitors, lithium, and sulfonamides.
• Calcium channel blocker, digoxin, or beta-adrenergic blockers.
• Has chronic use of opioids (including tramadol), defined as use 20 out of the last 30 days before study screening.
• Has