title: 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.
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.
authors.affiliation: Center for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA Gold Coast Research, LLC, Plantation, FL, USA Pfizer Inc, Durham, NC, USA Pfizer Inc, Groton, CT, USA Duke University Medical Center, Durham, NC, USA Pfizer Inc, New York, NY, USA (B. Setnik is now with INC Research, Raleigh, NC, USA; P. Meisner is now with UCB BioSciences, Raleigh, NC, USA; K. W. Sommerville is now with GW Pharmaceuticals, Research Triangle Park, NC, USA).
authors.forename: Richard L
authors.initials: RL
authors.lastname: Rauck
authors.forename: Martin E
authors.initials: ME
authors.lastname: Hale
authors.forename: Almasa
authors.initials: A
authors.lastname: Bass
authors.forename: Candace
authors.initials: C
authors.lastname: Bramson
authors.forename: Glenn
authors.initials: G
authors.lastname: Pixton
authors.forename: Jacquelyn G
authors.initials: JG
authors.lastname: Wilson
authors.forename: Beatrice
authors.initials: B
authors.lastname: Setnik
authors.forename: Paul
authors.initials: P
authors.lastname: Meisner
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Sommerville
authors.forename: Bimal K
authors.initials: BK
authors.lastname: Malhotra
authors.forename: Gernot
authors.initials: G
authors.lastname: Wolfram
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000097:blood / Q000627:therapeutic use*; D000704:Analysis of Variance; D059350:Chronic Pain / Q000097:blood / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D006801:Humans; D017116:Low Back Pain / Q000097:blood / Q000188:drug therapy*; D008875:Middle Aged; D009271:Naltrexone / Q000008:administration & dosage* / Q000097:blood; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000097:blood; D010098:Oxycodone / Q000097:blood / Q000627:therapeutic use*; D010147:Pain Measurement; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D009292:Narcotic Antagonists; D009271:Naltrexone; D010098:Oxycodone