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Date: Jun 17 2011

Mitigation of EtCO2 after Intravenous Injection of Morphine Sulfate and Naltrexone Hydrochloride

Mitigation of EtCO2, a Surrogate Measure of Respiratory Depression, After Intravenous Injection ofMorphine Sulfate and Naltrexone Hydrochloride.
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ABSTRACT

Aims: Respiratory depression (RD) is the leading cause of death following misuse/abuse of opioid drugs. When morphine is abused intravenously (IV), RD may occurwithin minutes and may become fatal within 3 hours of overdose; however, it maybe reversed by timely administration of an opioid antagonist. Unfortunately, timelyintervention is not always available. Morphine sulfate and naltrexone hydrochlorideextended release capsules (MS-sNT; EMBEDA®) contain pellets of extended-releasemorphine with a sequestered naltrexone core; when tampered with the pelletsrelease both morphine and naltrexone. When morphine and naltrexone wereadministered IV in the 25:1 ratio found in MS-sNT, naltrexone abated morphineinducedeuphoric effects. Hypothesis: In this study, morphine-induced RD willbe reduced following IV administration of morphine and naltrexone (25:1 ratio)vs IV morphine alone.

Methods: Exploratory analyses of end-tidal carbon dioxide (EtCO2) were performedduring a single-dose, 3-way crossover study comparing pharmacodynamic (PD)effects (Drug Liking, euphoria) of morphine sulfate 30 mg administered IV withnaltrexone HCl 1.2 mg vs IV morphine sulfate 30 mg administered alone or normalsaline (placebo) in 28 opioid-experienced, non–opioid-dependent men.

Results: Significant differences were detected in least squares means betweenactive treatment groups for maximum effect and partial area under the effect curves(p < 0.01). No difference was detected between the combination morphine +naltrexone and placebo groups in EtCO2 Emax levels (p = 0.3064), which emphasizednaltrexone’s PD effect of morphine displacement on the μ-opioid receptor.Conclusions: Results suggest that abuse of the MS-sNT formulation by extractionand injection could mitigate the risk of potentially fatal morphine-induced RD. Theuniqueness of this finding is that the harm reduction potential is already built intothe medicine.

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