Efficacy and Safety of Q8003 in the Management of Post-bunionectomy Pain

Inclusion Criteria:

• Patient is scheduled for bunionectomy surgery and is willing to stay in the studycenter for at least 48 hours from the initial dose of study medication post surgery.

• Females must be non-pregnant, non-lactating, and practicing an acceptable method ofbirth control, or be surgically sterile or postmenopausal (amenorrhea for ≥12 months).

• Patient has normal laboratory values or abnormal values judged not clinicallysignificant by the Investigator for clinical chemistry and hematology (< 1.5 ULN).

• Patient is in general good health based on physical examination, medical history andclinically acceptable results for the following assessments: vital signs and a 12-leadelectrocardiogram (ECG).

• Patient gives written informed consent and is able to understand the requirements ofthe study, adhere to the study restrictions, and be available for the requiredfollow-up assessment.

Exclusion Criteria:

• Patient has a current acute or chronic disease that would interfere with evaluationsof postoperative Q8003 efficacy or safety.

• Patient has a history of poor tolerance to short term opiate use in prior surgeries,based on patient self-report.

• Patient used opiates continuously (including tramadol) for more than five days in thepast year.

• Patient has a history of pulmonary, cardiovascular, neurologic, endocrine, hepatic,gastrointestinal, or kidney disease or therapy that, in the opinion of theInvestigator, would jeopardize the patient's well-being by participation in thisstudy.

• Patient has positive HIV serology or signs of HIV infection or AIDS.

• Patient has positive HBsAg or HCV antibody.

• Patient is currently receiving any medications that are not at a stable dose (the samedose for >2 month prior to date of surgery).

• Patient is currently receiving muscle relaxants, antipsychotic drugs, monoamineoxidase inhibitors, or any medications for the treatment of depression.

• Patient has used systemic corticosteroids within previous fourteen (14) days.

• Patient was dosed with another investigational drug within 30 days prior to theScreening Visit.

• Patient has current evidence of alcohol abuse (regularly drinks more than 4 units ofalcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).

• Patient has a history of abusing licit or illicit drug substances within five (5)years of study entry.

• Patient is obese with a body mass index >32.