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AcuroxTM (Oxycodone HCl/Niacin) tablets for the treatment of acute, moderate to severe pain following bunionectomy surgery in adult patients

2009; Elsevier BV; Volume: 10; Issue: 4 Linguagem: Inglês

10.1016/j.jpain.2009.01.144

1528-8447

S. Daniels, F. J. Clark, R. Spivey, Michael Golf, Eric Diamond, M. C. Robson, J. Zimmerman, Sonia Singla,

Musculoskeletal pain and rehabilitation

Prescription opioid analgesics, particularly short-acting opioids, are misused and abused by excessive ingestion of intact tablets, and by intra-nasal and intravenous administration. Thus, there is a clear need for short-acting opioids designed to discourage inappropriate use. Acurox™ Tablets (Acurox™) are a unique combination of short-acting oxycodone HCl for the treatment of moderate to severe pain, and niacin. At doses that exceed the recommended 2-tablet dose, Acurox™ is associated with niacin-induced unpleasant, yet reversible, dysphoric effects. Additional functional excipients challenge common physical and chemical manipulations. Analgesic efficacy and safety of Acurox™ were evaluated in a Phase III study of adults with acute, moderate to severe pain following bunionectomy surgery. After meeting eligibility criteria, 405 patients were randomized in a 1:1:1 ratio to receive 2 Acurox™ (oxycodone HCl/niacin) Tablets 7.5/30mg, 2 Acurox™ Tablets 5/30mg, or placebo every 6 hours for 48 hours after surgery. Both Acurox™ doses demonstrated significantly superior reductions in pain intensity compared with placebo as evidenced by the primary endpoint, the time-weighted sum of pain intensity differences over 48 hours (SPID48; P < 0.0001 and P = 0.0001 for Acurox™ 2 x 7.5/30mg and Acurox™ 2 x 5/30mg, respectively). Analysis of secondary efficacy measures, including responder analysis, mean patient average daily pain intensity (MPADPI), and time-weighted total pain relief (TOTPAR6) over 6 hours following first administration, confirmed that each dose level was significantly superior to placebo. Six patients discontinued treatment with Acurox™ because of treatment-emergent adverse events (AEs); 2 patients (1.5%) in the Acurox™ 5/30 group and 4 patients (3.0%) in the Acurox™ 7.5/30 group. AEs were consistent with known effects of oxycodone HCl and niacin, most were reported as mild or moderate in severity, and no serious AEs occurred. This is the first large clinical study demonstrating the efficacy and safety of a short-acting opioid composition designed to deter excessive oral ingestion. (Supported by a grant from Acura Pharmaceuticals, Inc.)