title: Buprenorphine-naloxone buccal soluble film for the treatment of opioid dependence: current update.
abstract: BACKGROUND
  Opioid dependence is a severe medical disorder with a high psychiatric and somatic comorbidity and mortality rate. The opioid agonist methadone, mixed agonist-antagonist buprenorphine and the combination of buprenorphine with the opioid antagonist naloxone are the first-line maintenance treatments for opioid dependence. Risk of diversion and accidental intoxications, especially in children, are of great concern. To lower these risks, a novel buprenorphine-naloxone film has been developed and introduced in the USA and Australia.
  
  
  METHODS
  This review evaluates the available preclinical and clinical data on the novel buprenorphine-naloxone film for treatment of opioid dependence. Literature was identified through a comprehensive PubMed search. Data sources also included official FDA information and material made public by the manufacturer.
  
  
  CONCLUSIONS
  Few preclinical and clinical data on safety and efficacy have been published. The pharmacological differences between the novel film and the conventional buprenorphine/naloxone are small. In an experimental study, the new formulation suppressed symptoms of opioid withdrawal. The spectrum of adverse events seems to be similar to that of the conventional sublingual tablet. Recent data show that patients prefer the novel film over the conventional sublingual tablet. Emerging surveillance data indicate a lower risk of accidental poisoning in children compared with the conventional formulation. Further clinical and preclinical data are needed to explore additional possible advantages of the new formulation.
authors.affiliation: Ludwig Maximilian University, Department of Psychiatry , Munich , Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Soyka
mesh_terms: D000701:Analgesics, Opioid / Q000009:adverse effects; D002047:Buprenorphine / Q000008:administration & dosage* / Q000627:therapeutic use; D000069479:Buprenorphine, Naloxone Drug Combination; D002626:Chemistry, Pharmaceutical; D006801:Humans; D009270:Naloxone / Q000008:administration & dosage* / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D013607:Tablets
chemical_list: D000701:Analgesics, Opioid; D000069479:Buprenorphine, Naloxone Drug Combination; D009292:Narcotic Antagonists; D013607:Tablets; D009270:Naloxone; D002047:Buprenorphine
keywords: buprenorphine; buprenorphine film; naloxone; opioid dependence; opioids; pharmacotherapy