Intranasal administration of crushed ALO-02 (extended-release oxycodone with sequestered naltrexone): A randomized, controlled abuse-potential study in nondependent recreational opioid users

2015 ◽  
Vol 55 (12) ◽  
pp. 1351-1361 ◽  
Author(s):  
Beatrice Setnik ◽  
Candace Bramson ◽  
Almasa Bass ◽  
Naama Levy-Cooperman ◽  
Bimal Malhotra ◽  
...  
Keyword(s):  
Intranasal Administration ◽  
Extended Release ◽  
Abuse Potential ◽  
Randomized Controlled ◽  
Potential Study ◽  
Opioid Users

scholarly journals Intranasal Pharmacokinetics of Morphine ARER, a Novel Abuse-Deterrent Formulation: Results from a Randomized, Double-Blind, Four-Way Crossover Study in Nondependent, Opioid-Experienced Subjects

2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Lynn R. Webster ◽  
Carmela Pantaleon ◽  
Matthew Iverson ◽  
Michael D. Smith ◽  
Eric R. Kinzler ◽  
...  
Keyword(s):  
Crossover Study ◽  
Intranasal Administration ◽  
Extended Release ◽  
Oral Morphine ◽  
Abuse Potential ◽  
Maximum Effect ◽  
Double Blind ◽  
Opioid Users ◽  
Physical Manipulation ◽  
Drug Liking

Objective. To investigate the pharmacokinetics (PK) of Morphine ARER, an extended-release (ER), abuse-deterrent formulation of morphine sulfate after oral and intranasal administration. Methods. This randomized, double-blind, double-dummy, placebo-controlled, four-way crossover study assessed the PK of morphine and its active metabolite, M6G, from crushed intranasal Morphine ARER and intact oral Morphine ARER compared with crushed intranasal ER morphine following administration to nondependent, recreational opioid users. The correlation between morphine PK and the pharmacodynamic parameter of drug liking, a measure of abuse potential, was also evaluated. Results. Mean maximum observed plasma concentration (Cmax) for morphine was lower with crushed intranasal Morphine ARER (26.2 ng/mL) and intact oral Morphine ARER (18.6 ng/mL), compared with crushed intranasal ER morphine (49.5 ng/mL). The time to Cmax (Tmax) was the same for intact oral and crushed intranasal Morphine ARER (1.6 hours) and longer for crushed intranasal morphine ER (1.1 hours). Higher mean maximum morphine Cmax, Tmax, and abuse quotient (Cmax/Tmax) were positively correlated with maximum effect for drug liking (R2 ≥ 0.9795). Conclusion. These data suggest that Morphine ARER maintains its ER profile despite physical manipulation and intranasal administration, which may be predictive of a lower intranasal abuse potential compared with ER morphine.

scholarly journals Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users

Pain Medicine ◽  
2017 ◽  
Vol 19 (8) ◽  
pp. 1597-1612
Author(s):  
Mary Bond ◽  
Kerri A Schoedel ◽  
Laura Rabinovich-Guilatt ◽  
Maciej Gasior ◽  
William Tracewell ◽  
...  
Keyword(s):  
Extended Release ◽  
Abuse Potential ◽  
Opioid Users ◽  
Extended Release Tablet ◽  
Release Tablet
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