title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Intranasal Drug Liking Study on a Novel Abuse-Deterrent Formulation of Morphine-Morphine ARER.
abstract: OBJECTIVE
  Misuse and abuse of prescription opioids remains a major healthcare concern despite considerable efforts to increase public awareness. Abuse-deterrent formulations of prescription opioids are designed to reduce intentional misuse, abuse, and prescription opioid-related death. A novel extended-release (ER) formulation of morphine (Morphine ARER; MorphaBond™) resists physical manipulation and retains the drug's ER characteristics, even if attempts are made to manipulate the formulation.
  
  
  METHODS
  This randomized, double-blind, double-dummy, placebo-controlled, four-way crossover study investigated the abuse potential and safety of crushed intranasal and intact oral Morphine ARER compared with commercially available crushed intranasal ER morphine sulfate (ER morphine).
  
  
  METHODS
  Endpoints included maximum mean drug liking (E max ) as measured by subjects on a bipolar 100 mm visual analog scale (primary), a subject's desire to take the drug again, good effects of the drug, and drug high.
  
  
  RESULTS
  Twenty-five subjects completed the treatment phase. There was a 40% reduction in E max for crushed intranasal Morphine ARER compared with crushed intranasal ER morphine ( P  < .0001). There was no significant difference when comparing the E max for crushed intranasal vs intact Morphine ARER. When comparing crushed intranasal Morphine ARER with ER morphine, subjects reported lower mean scores for good effects of the drug, drug high, and overall drug liking, as well as a lower desire to use Morphine ARER again. Other than adverse events associated with intranasal administration of a drug, all adverse events were typical of those reported for opioid-containing drugs.
  
  
  CONCLUSIONS
  Overall, these data suggest that Morphine ARER has a lower abuse potential via the intranasal route of administration when compared with ER morphine.
authors.affiliation: PRA Health Sciences, Salt Lake City, Utah.
authors.forename: Lynn R
authors.initials: LR
authors.lastname: Webster
authors.affiliation: Inspirion Delivery Technologies, LLC, Valley Cottage, New York.
authors.forename: Carmela
authors.initials: C
authors.lastname: Pantaleon
authors.affiliation: Cerovene, Inc., Valley Cottage, New York, USA.
authors.forename: Manish S
authors.initials: MS
authors.lastname: Shah
authors.affiliation: Cerovene, Inc., Valley Cottage, New York, USA.
authors.forename: Ray
authors.initials: R
authors.lastname: DiFalco
authors.affiliation: Inspirion Delivery Technologies, LLC, Valley Cottage, New York.
authors.forename: Matthew
authors.initials: M
authors.lastname: Iverson
authors.affiliation: PRA Health Sciences, Salt Lake City, Utah.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Smith
authors.affiliation: Inspirion Delivery Technologies, LLC, Valley Cottage, New York.
authors.forename: Eric R
authors.initials: ER
authors.lastname: Kinzler
authors.affiliation: Inspirion Delivery Technologies, LLC, Valley Cottage, New York.
authors.forename: Stefan
authors.initials: S
authors.lastname: Aigner
mesh_terms: D000075162:Abuse-Deterrent Formulations / Q000379:methods*; D000281:Administration, Intranasal; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000737:chemistry; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000737:chemistry; D004311:Double-Blind Method; D004339:Drug Compounding; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009020:Morphine / Q000008:administration & dosage* / Q000737:chemistry; D009293:Opioid-Related Disorders / Q000188:drug therapy* / Q000523:psychology; D055815:Young Adult
chemical_list: D000075162:Abuse-Deterrent Formulations; D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D009020:Morphine
keywords: Abuse Deterrent; Opioid Abuse; Pain; Snorting