Post-operative Efficacy and Safety Study

A Randomized, Double-blind Evaluation of the Analgesic Efficacy and Safety of a Low Dose Oxymorphone Immediate Release in Patients Following Ambulatory Arthroscopic Knee Surgery

The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.

Inclusion Criteria:

• Males or females, 18 years of age or older, who have completed outpatient knee arthroscopy
• Have an initial pain intensity score of between 30mm and 70mm on a 100mm Visual Analogue Scale(VAS) and a categorical pain rating scale of none, mild, moderate, or severe,
• Have been informed of the nature of the study and provided written informed consent

Exclusion Criteria:

• Have a positive pregnancy test
• Have received any of the following medications within 24 hours prior to dosing: COX2 inhibitors, Minor Tranquilizers, Muscle relaxants, Antihistamines
• Long-acting oral and parenteral analgesics are prohibited for at least 12 hours prior to receiving study medication.
• Have received any of the following medication within 48 hours prior to dosing: Chronic use of analgesics (opioid or non-opioid including aspirin [>325 mg/day], acetaminophen, and NSAIDs)
• Have received MAOI drugs within 2 weeks prior to dosing
• Not stabilized on the following medications for at least 4 weeks prior to dosing: Tricyclic antidepressant drugs, Serotonin reuptake inhibitors, Amphetamines used for ADHD