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Abuse Deterrent Formulation

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Stefan Aigner – One of the best experts on this subject based on the ideXlab platform.

  • A Randomized, Crossover Study on the Effect of Food on the Pharmacokinetic Characteristics of Morphine ARER (MorphaBond™ ER), an AbuseDeterrent Formulation of Extended-Release Morphine.
    Advances in Therapy, 2019
    Co-Authors: Eric R. Kinzler, Carmela Pantaleon, Matthew Iverson, Stefan Aigner

    Abstract:

    Introduction
    Food can alter the pharmacokinetics of certain AbuseDeterrent Formulations. Morphine ARER is an oral AbuseDeterrent Formulation of ER morphine sulfate tablets formulated with physical and chemical properties that contribute to the AbuseDeterrent aspects of the drug. This study compared the relative bioavailability of Morphine ARER in the presence and absence of food.

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  • Syringeability of morphine ARER, a novel, AbuseDeterrent, extended-release morphine Formulation
    The American Journal of Drug and Alcohol Abuse, 2019
    Co-Authors: Eric R. Kinzler, Carmela Pantaleon, Matthew Iverson, Stefan Aigner

    Abstract:

    Background: Extended-release (ER) morphine Formulations are commonly manipulated for non-oral routes of administration, particularly via injection. Morphine ARER, an AbuseDeterrent Formulation of …

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  • 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, 2019
    Co-Authors: Lynn R. Webster, Eric R. Kinzler, Carmela Pantaleon, Matthew Iverson, Michael D. Smith, Stefan Aigner

    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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Lynn R. Webster – One of the best experts on this subject based on the ideXlab platform.

  • 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, 2019
    Co-Authors: Lynn R. Webster, Eric R. Kinzler, Carmela Pantaleon, Matthew Iverson, Michael D. Smith, Stefan Aigner

    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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  • Intranasal Pharmacokinetics of Morphine ARER, a Novel AbuseDeterrent Formulation: Results from a Randomized, Double-Blind, Four-Way Crossover Study in Nondependent, Opioid-Experienced Subjects.
    Pain Research and Management, 2018
    Co-Authors: Lynn R. Webster, Eric R. Kinzler, Carmela Pantaleon, Matthew Iverson, Michael D. Smith, Stefan Aigner

    Abstract:

    Objective. To investigate the pharmacokinetics (PK) of Morphine ARER, an extended-release (ER), AbuseDeterrent 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.

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  • A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Intranasal Drug Liking Study on a Novel AbuseDeterrent Formulation of Morphine—Morphine ARER
    Pain Medicine, 2016
    Co-Authors: Lynn R. Webster, Eric R. Kinzler, Carmela Pantaleon, Matthew Iverson, Michael D. Smith, Manish S. Shah, Ray J. Difalco, Stefan Aigner

    Abstract:

    Objective.  Misuse and Abuse of prescription opioids remains a major healthcare concern despite considerable efforts to increase public awareness. AbuseDeterrent 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.

    Design.  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).

    Outcome Measures.  Endpoints included maximum mean drug liking (Emax) 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 Emax for crushed intranasal Morphine ARER compared with crushed intranasal ER morphine ( P 

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Michael D. Smith – One of the best experts on this subject based on the ideXlab platform.

  • 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, 2019
    Co-Authors: Lynn R. Webster, Eric R. Kinzler, Carmela Pantaleon, Matthew Iverson, Michael D. Smith, Stefan Aigner

    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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  • Intranasal Pharmacokinetics of Morphine ARER, a Novel AbuseDeterrent Formulation: Results from a Randomized, Double-Blind, Four-Way Crossover Study in Nondependent, Opioid-Experienced Subjects.
    Pain Research and Management, 2018
    Co-Authors: Lynn R. Webster, Eric R. Kinzler, Carmela Pantaleon, Matthew Iverson, Michael D. Smith, Stefan Aigner

    Abstract:

    Objective. To investigate the pharmacokinetics (PK) of Morphine ARER, an extended-release (ER), AbuseDeterrent 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.

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  • A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Intranasal Drug Liking Study on a Novel AbuseDeterrent Formulation of Morphine—Morphine ARER
    Pain Medicine, 2016
    Co-Authors: Lynn R. Webster, Eric R. Kinzler, Carmela Pantaleon, Matthew Iverson, Michael D. Smith, Manish S. Shah, Ray J. Difalco, Stefan Aigner

    Abstract:

    Objective.  Misuse and Abuse of prescription opioids remains a major healthcare concern despite considerable efforts to increase public awareness. AbuseDeterrent 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.

    Design.  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).

    Outcome Measures.  Endpoints included maximum mean drug liking (Emax) 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 Emax for crushed intranasal Morphine ARER compared with crushed intranasal ER morphine ( P 

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