scholarly journals Abuse Potential Study of ALO-02 (Extended-Release Oxycodone Surrounding Sequestered Naltrexone) Compared with Immediate-Release Oxycodone Administered Orally to Nondependent Recreational Opioid Users

Pain Medicine ◽  
2016 ◽  
pp. pnw178 ◽  
Author(s):  
Beatrice Setnik ◽  
Almasa Bass ◽  
Candace Bramson ◽  
Naama Levy-Cooperman ◽  
Bimal Malhotra ◽  
...  
Keyword(s):  
Extended Release ◽  
Immediate Release ◽  
Abuse Potential ◽  
Potential Study ◽  
Opioid Users

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

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 A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Intranasal Human Abuse Potential Study of Oxycodone ARIR, a Novel, Immediate-Release, Abuse-Deterrent Formulation

Pain Medicine ◽  
2018 ◽  
Vol 20 (4) ◽  
pp. 747-757 ◽  
Author(s):  
Lynn R Webster ◽  
Matthew Iverson ◽  
Carmela Pantaleon ◽  
Michael D Smith ◽  
Eric R Kinzler ◽  
...  
Keyword(s):  
Peak Concentration ◽  
Plasma Concentrations ◽  
Immediate Release ◽  
Abuse Potential ◽  
Health Concern ◽  
Prescription Opioid ◽  
Double Blind ◽  
Time To Peak ◽  
Potential Study ◽  
Drug Liking

Abstract Objective Prescription opioid abuse continues to be a public health concern. Oxycodone ARIR is an immediate-release (IR) oxycodone tablet composed of multiple overlapping barriers that deter manipulation of the tablet for non-oral abuse. Design This randomized, double-blind, double-dummy, active- and placebo-controlled, four-way crossover, intranasal human abuse potential study assessed the pharmacodynamics and pharmacokinetics of crushed intranasal oxycodone ARIR compared with crushed intranasal IR oxycodone and intact oral oxycodone ARIR. Outcome Measures Pharmacodynamic end points included mean maximum drug liking (Emax), as measured by subjects on a bipolar 100-mm visual analog scale (primary), and desire to take the drug again, overall drug liking, drug high, and good effects (secondary). Pharmacokinetic assessments included peak concentration and time to peak concentration. Results Twenty-nine subjects completed the treatment phase. Crushed intranasal oxycodone ARIR demonstrated a significant reduction of 46.9% and 23.4% in drug liking Emax compared with crushed intranasal IR oxycodone and intact oral oxycodone ARIR, respectively (P < 0.0001 for both). Significant reductions also were observed in desire to take the drug again, drug high, overall drug liking, and good effects when comparing crushed intranasal oxycodone ARIR with crushed intranasal IR oxycodone and intact oral oxycodone ARIR (P < 0.001 for all). Crushed intranasal oxycodone ARIR exhibited lower peak oxycodone plasma concentrations and slower time to peak concentration compared with crushed intranasal IR oxycodone and intact oral oxycodone ARIR. All treatments were well tolerated; adverse effects were typical of opioids or intranasal administration. Conclusions These data indicate that oxycodone ARIR has the potential to reduce abuse via the intranasal route.

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