Study AP-ADF-105

Product: Acurox® Tablets
Study: AP-ADF-105 or Study 105
Phase: Phase III
Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Repeat-dose Study of the Safety and Efficacy of Acurox (oxycodone HCl and niacin) Tablets versus Placebo for the Treatment of Acute, Moderate to Severe Postoperative Pain Following Bunionectomy Surgery in Adult Patients

Study Objective

To evaluate safety and efficacy of Acurox in relieving moderate to severe pain.

Design Summary

A total of 405 patients were randomized to one of three treatment arms of approximately 135 patients per arm. One treatment arm received a dose of two Acurox Tablets 5/30 mg, a second treatment arm received a dose of two Acurox Tablets 7.5/30 mg, and the third treatment arm received a dose of two placebo tablets. Study drugs were administered every 6 hours for 48 hours following bunionectomy surgery. The primary endpoint was the sum of the difference in pain intensity, measured on a 100mm visual analog scale (VAS), compared to baseline over a 48 hour period (“SPID48”). Prior to initiating Study 105, the study design, endpoints and statistical analysis plan were submitted to and agreed by the FDA under a Special Protocol Assessment and the study was conducted accordingly.

Results Summary

Study 105 results demonstrated that, compared to placebo, Acurox Tablets 5/30 mg and 7.5/30 mg both met the primary pain relief endpoint with p=.0001 and p<.0001, respectively. Acurox Tablets were generally well tolerated with the most prevalent reported adverse events in patients receiving Acurox Tablets being nausea, vomiting, dizziness, pruritus and flushing; side effects known to be consistent with opioid and niacin therapies. Most adverse events were mild or moderate and there were no serious adverse events. Six patients (2.2%) receiving Acurox Tablets withdrew from the study due to treatment–emergent adverse events compared with no withdrawals due to treatment-emergent adverse events for the placebo group.