title: Efficacy of Buprenorphine/Naloxone Rapidly Dissolving Sublingual Tablets (BNX-RDT) After Switching From BNX Sublingual Film.
abstract: OBJECTIVE
  The aim of the study was to evaluate treatment retention, efficacy, and preference ratings among opioid-dependent patients transitioning between a buprenorphine/naloxone rapidly dissolving sublingual tablet formulation (BNX-RDT) and BNX film.
  
  
  METHODS
  After a 2-day, blinded, fixed-dose induction with BNX-RDT (5.7/1.4 mg and 5.7/1.4 or 11.4/2.8 mg, respectively) or buprenorphine (8 mg and 8 or 16 mg, respectively), patients received open-label titrated doses of BNX-RDT or BNX film (generic buprenorphine induction group) during days 3 to 14. On day 15, patients switched treatment (using a conversion ratio of 5.7-8 mg) and continued switched treatment through day 22. Assessments included treatment retention, opioid withdrawal (Clinical and Subjective Opiate Withdrawal scales), opioid cravings (0-100 visual analog scale [VAS]), and preference ratings.
  
  
  RESULTS
  Of the 287 patients who switched from BNX-RDT to BNX film and 279 patients who switched from BNX film to BNX-RDT at day 15, 8.7% and 6.1% withdrew, respectively. Reductions in opioid withdrawal and cravings were similar with both formulations through day 15; after switching treatment, reductions were maintained through day 22 in both groups. Preference ratings at day 22 (patients had received both formulations) favored BNX-RDT for taste, mouthfeel, ease of administration, and overall preference (all P < 0.0001).
  
  
  CONCLUSIONS
  In both patient groups who switched treatment at day 15, more than 90% were retained in treatment, and reductions in opioid withdrawal and cravings were sustained. A significant majority of patients preferred BNX-RDT over BNX film, the clinical impact of which requires further study.
authors.affiliation: University of Virginia, Charlottesville, VA (EWG); and Orexo US, Inc., Morristown, NJ (MS).
authors.forename: Erik W
authors.initials: EW
authors.lastname: Gunderson
authors.forename: Michael
authors.initials: M
authors.lastname: Sumner
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000069479:Buprenorphine, Naloxone Drug Combination / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D066249:Craving / Q000187:drug effects; D004304:Dosage Forms; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D010349:Patient Compliance; D057240:Patient Preference; D016037:Single-Blind Method; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D000069479:Buprenorphine, Naloxone Drug Combination; D004304:Dosage Forms; D009292:Narcotic Antagonists