A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment. Issue 9 (September 2015)

• Record Type: Journal Article
• Authors: Rauck, Richard L.; Hale, Martin E.; Bass, Almasa; Bramson, Candace; Pixton, Glenn; Wilson, Jacquelyn G.; Setnik, Beatrice; Meisner, Paul; Sommerville, Kenneth W.; Malhotra, Bimal K.; Wolfram, Gernot
• Is Part Of: Pain. Volume 156:Issue 9(2015)
• Publication Date: 2015-09
• Subjects: ALO-02 -- Oxycodone -- Naltrexone -- Abuse-deterrent formulation -- Chronic low back pain; Pain -- Periodicals; Douleur -- Périodiques; Anesthésie -- Périodiques; Pain; Electronic journals; Periodicals; Electronic journals; 616.0472
• DOI: 10.1097/j.pain.0000000000000230
• Languages: English
• ISSNs: 0304-3959

Abstract

Abstract : Abstract: The objective of this multicenter, double-blind, placebo-controlled, randomized withdrawal study was to evaluate the efficacy and safety of ALO-02, an abuse-deterrent formulation containing pellets of extended-release oxycodone hydrochloride (HCl) surrounding sequestered naltrexone HCl, compared with placebo in the treatment of moderate-to-severe chronic low back pain. An open-label titration period in which all patients received ALO-02 was followed by a double-blind treatment period where patients meeting treatment response criteria were randomized to either a fixed dose of ALO-02 or placebo. Daily average low back pain was assessed using an 11-point numeric rating scale (NRS)-Pain. Of the 663 patients screened, 410 received ALO-02 during the open-label conversion and titration period and 281 patients were randomized to the double-blind treatment period (n = 134, placebo; n = 147, ALO-02). Change in the mean NRS-Pain score from randomization baseline to the final 2 weeks of the treatment period was significantly different favoring ALO-02 compared with placebo ( P = 0.0114). Forty-four percent of patients treated with placebo and 57.5% of patients treated with ALO-02 reported ≥30% improvement in weekly average NRS-Pain scores from screening to the final 2 weeks of the treatment period ( P = 0.0248). In the double-blind treatment period, 56.8% of patients in the ALO-02 group and 56.0% of patients in the placebo group experienced a treatment-emergent adverse event (TEAE). The most common treatment-related TEAEs for ALO-02 during the treatment period were nausea, vomiting, and constipation, consistent with opioid therapy. ALO-02 has been demonstrated to provide significant reduction of pain in patients with chronic low back pain and has a safety profile similar to other opioids. Abstract : ALO-02, an abuse-deterrent formulation containing pellets of extended-release oxycodone hydrochloride surrounding sequestered naltrexone hydrochloride, was efficacious and tolerated in a similar manner to other opioids in treating chronic low back pain.