Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients

This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.

• Drug: Q8003
  One Q8003 (morphine sulfate and oxycodone HCl) 12mg/8mg IR Capsule q6h
• Drug: Morphine sulfate
  One morphine sulfate 12mg IR capsule q6h
• Drug: Oxycodone HCl
  One oxycodone HCl 8mg IR Capsule q6h
• Drug: Q8003
  One Q8003 (morphine sulfate and oxycodone HCl) 6mg/4mg IR Capsule q6h
• Drug: Morphine sulfate
  Two morphine sulfate 3mg IR capsules q6h
• Drug: Oxycodone HCl 4mg
  Two oxycodone HCl 2mg IR Capsules q6h

• Experimental: Q8003 12mg/8mg
  Combination
  Intervention: Drug: Q8003
• Active Comparator: Morphine sulfate 12 mg
  Single component
  Intervention: Drug: Morphine sulfate
• Active Comparator: Oxycodone HCl 8mg
  Single component
  Intervention: Drug: Oxycodone HCl
• Experimental: Q8003 6mg/4mg
  Combination
  Intervention: Drug: Q8003
• Active Comparator: Morphine sulfate 6mg
  Single component
  Intervention: Drug: Morphine sulfate
• Active Comparator: Oxycodone HCl 4mg
  Single component
  Intervention: Drug: Oxycodone HCl 4mg

Inclusion Criteria:

• Patient is male or female and at least 18 years of age.
• Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). Non-pregnancy will be confirmed by pregnancy tests conducted at Screening and Pre-treatment.
• Patient is scheduled for bunionectomy surgery, meets the criteria of an ASA Class I to III, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery.
• To be randomized after surgery, the patient must report moderate to severe pain (a score of 2 or more on the 4 point Likert scale or at least 4 on the 11 point NPRS scale).

Exclusion Criteria:

• In the opinion of the Investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that, in the opinion of the Investigator, would jeopardize the patient's well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
• Used opiates continuously (including tramadol) for more than ten days in the past year.
• Hypersensitivity or poor tolerance to ibuprofen or short term opioids.
• Currently receiving any medications that are not at a stable dose (the same dose for > 2 months prior to date of surgery).
• Was dosed with another investigational drug within 30 days prior to the Screening Visit or has previously received treatment with Q8003.
• Current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia).
• Current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).