Clinical abuse potential study - Bioavailability

Clinical abuse potential study—INTRANASAL PK DATA

MORPHABOND ER Is Formulated to Prevent Dose Dumping by Maintaining
Similar Morphine Concentrations Even When Manipulated1,2

 

Mean Plasma Concentration

This study was not powered for comparisons of Cmax, Tmax, or area under the curve (AUC).
 
These data demonstrate that even if manipulated, MORPHABOND ER retains its extended-release properties
Abuse of MORPHABOND ER is still possible by intranasal, intravenous, and oral routes

Study design: The intranasal abuse potential and relative bioavailability of MORPHABOND ER was evaluated in a randomized, double-blind, double-dummy, placebo-controlled, single-dose, 4-way crossover study in 25 nondependent recreational opioid users comparing crushed intranasal MORPHABOND ER 60 mg, crushed intranasal MS Contin® 60 mg, and intact oral MORPHABOND ER 60 mg.

  • Primary endpoint: mean maximum effect (Emax) for drug liking between crushed intranasal MORPHABOND ER and crushed intranasal MS Contin®
  • Secondary comparisons for the primary endpoint included Emax for intact oral MORPHABOND ER compared with crushed intranasal MS Contin® and crushed intranasal MORPHABOND ER
  • Other secondary endpoints included Take Drug Again assessments and determining the relative bioavailability of morphine in plasma for crushed intranasal and intact oral MORPHABOND ER compared with crushed intranasal MS Contin®
  • Drug Liking (primary) and Take Drug Again (secondary) endpoints were measured on a 100-mm bipolar visual analog scale (VAS) where 50 represents a neutral response, 0 represents the strongest negative response, and 100 represents the strongest positive response

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