title: Buprenorphine and buprenorphine/naloxone soluble-film for treatment of opioid dependence.
abstract: BACKGROUND
  Opioid dependence is a chronic relapsing disorder that shows excess mortality and comorbidity with somatic and psychiatric disorders. Methadone and buprenorphine/naloxone are widely accepted and are used as first-line maintenance treatments for opioid dependence. Fatal intoxications with these agents, risk of diversion, and accidental intoxications, especially in children, are apparent risks and are of increasing public concern. Buprenorphine/naloxone sublingual tablet is an established treatment for opioid dependence. A novel buprenorphine/naloxone film has been developed with improved pharmacokinetics and a hopefully lower risk of diversion and accidental intoxications.
  
  
  METHODS
  This review evaluates the available preclinical and clinical data on the novel buprenorphine/naloxone film for the treatment of opioid dependence. Literature was identified though a comprehensive PubMed search and data sources included official FDA information.
  
  
  CONCLUSIONS
  This is an interesting new formulation of a well-established medication in opioid dependence. However, few data have been published on its safety and efficacy. In an experimental study, the new formulation suppressed symptoms of opioid withdrawal as expected. Results of an unpublished study made public by the FDA suggest a spectrum of adverse events similar to that of the conventional sublingual tablet. Some data show patients may prefer the novel film over the sublingual tablet. The estimated lower risk for diversion and especially for accidental poisoning in children cannot be assessed in clinical studies but requires data from emergency room visits.
authors.affiliation: University of Munich, Psychiatric Hospital, Nussbaumstr. 7 Munich Munich, Germany. Michael.Soyka@privatklinik-meiringen.ch
authors.forename: Michael
authors.initials: M
authors.lastname: Soyka
mesh_terms: D000818:Animals; D002047:Buprenorphine / Q000008:administration & dosage* / Q000493:pharmacokinetics; D000069479:Buprenorphine, Naloxone Drug Combination; D004337:Drug Carriers; D004338:Drug Combinations; D004339:Drug Compounding; D006801:Humans; D009270:Naloxone / Q000008:administration & dosage* / Q000493:pharmacokinetics; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000493:pharmacokinetics; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D013607:Tablets
chemical_list: D000069479:Buprenorphine, Naloxone Drug Combination; D004337:Drug Carriers; D004338:Drug Combinations; D009292:Narcotic Antagonists; D013607:Tablets; D009270:Naloxone; D002047:Buprenorphine