title: Assessment of the safety and efficacy of extended-release oxycodone/acetaminophen, for 14 days postsurgery.
abstract: OBJECTIVE
  To investigate the safety and satisfaction of patients treated ≤ 14 days after unilateral bunionectomy with extended-release oxycodone/acetaminophen (ER OC/APAP), a biphasic (ER and immediate release) fixed-dose combination analgesic being developed for moderate to severe acute pain.
  
  
  METHODS
  This was an open-label extension (OLE) of a randomized, double-blind, placebo-controlled trial (DBRCT) of patients undergoing bunionectomy. Patients who consented to the OLE before entering the 48 hour DBRCT entered the OLE upon completing the DBRCT and during the OLE received two tablets of ER OC/APAP (15/650 mg total dose) every 12 hours for ≤ 14 days. ClinicalTrials identifier: NCT01484652.
  
  
  METHODS
  Treatment-emergent adverse events, physical examinations, vital sign measurements, and clinical laboratory testing were assessed throughout the study. Global assessments of treatment satisfaction were made at the end of the DBRCT and at each clinic visit during the OLE.
  
  
  RESULTS
  A total of 146 patients consented to the OLE before entering the DBRCT and 129 completed the OLE. Tolerability of ER OC/APAP during the OLE was consistent with that of an opioid product. Adverse events occurred during the OLE in 64 patients (43.8%); the most common were gastrointestinal events including nausea (17.8%), vomiting (7.5%), and constipation (6.2%). No changes in vital signs or clinical laboratory tests were considered by the investigator to be clinically significant. At all visits during the OLE, the majority of patients were satisfied or very satisfied with their medication. Limitations include a 14 day postprocedure study duration that may be confounded with natural healing time, and lack of a placebo arm.
  
  
  CONCLUSIONS
  These results show that ER OC/APAP demonstrated an expected safety and tolerability profile and good patient satisfaction in a postsurgical model of acute pain.
authors.affiliation: Lotus Clinical Research LLC, Huntington Hospital, Department of Anesthesia , Pasadena, CA , USA.
authors.forename: Neil
authors.initials: N
authors.lastname: Singla
authors.forename: Thomas
authors.initials: T
authors.lastname: Barrett
authors.forename: Lisa
authors.initials: L
authors.lastname: Sisk
authors.forename: Kenneth
authors.initials: K
authors.lastname: Kostenbader
authors.forename: Jim
authors.initials: J
authors.lastname: Young
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage*; D059787:Acute Pain / Q000188:drug therapy* / Q000209:etiology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006215:Hallux Valgus / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019637:Orthopedic Procedures / Q000009:adverse effects*; D010098:Oxycodone / Q000008:administration & dosage*; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D017060:Patient Satisfaction; D013607:Tablets; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D013607:Tablets; C514822:oxycodone-acetaminophen; D000082:Acetaminophen; D010098:Oxycodone
keywords: Acetaminophen – Acute pain – Extended release – Oxycodone