Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy

This was a Phase III, randomized, double blind, placebo controlled, multicenter, repeat dose study of the safety and efficacy of 2 dose levels of Acurox™ Tablets versus placebo for the treatment of moderate to severe postoperative pain following bunionectomy surgery.

Patients underwent a primary unilateral first metatarsal bunionectomy with or without ipsilateral hammer toe repair during standardized local anesthesia with intravenous (IV) sedation. Eligible patients who reported moderate or severe pain within 6 hours after surgery entered the Treatment Phase and were randomized to 1 of 3 double blind treatments: placebo tablets or 1 of 2 dose levels of Acurox™ Tablets (ocyxcodone HCl/niacin). The Treatment Phase continued with study medication every 6 hours (irrespective of rescue medication use) for 48 hours (8 doses of study medication). Toradol (ketorolac tromethamine) was available as a rescue medication upon request.

Inclusion criteria

• Patient is male or female at least 18 years of age
• For women of child-bearing potential: woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
• Patient is scheduled to have a bunionectomy
• Patient must be willing to stay at the study site for at least 48 hours from the initial dose of study medication post-surgery

Exclusion criteria

• Patient has a current disease or history of a disease that will impact the study or the patient's well-being
• Patient has used or intends to use any of the medications that are prohibited by the protocol
• Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen
• Patient is hypersensitive to any of the medications to be used in the study
• Patient has taken another investigational drug within 30 days prior to Screening