Compositions and methods for opioid antagonist delivery
AssigneePurdue Pharma L.P.
InventorsHaiyong Hugh Huang, Manjunath S. Shet
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Abstract
Disclosed in certain embodiments is a pharmaceutical formulation (e.g., parenteral formulation) comprising a therapeutically effective amount of nalmefene or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable adjuvant (e.g., parenterally acceptable adjuvant) that promotes the rate at which the nalmefene or salt thereof is more rapidly absorbed into the systemic circulation of a subject identified as in need thereof.
Claims26
A parenteral formulation comprising a therapeutically effective amount of nalmefene or a pharmaceutically acceptable salt thereof and a parenterally acceptable absorption enhancing amount of an adjuvant, wherein the formulation provides a time to onset of opioid antagonistic action of less than 5 minutes post administration via an intramuscular or subcutaneous injection to a subject experiencing an opioid agonist overdose.
A parenteral formulation comprising a therapeutically effective amount of nalmefene or a pharmaceutically acceptable salt thereof and a parenterally acceptable absorption enhancing amount of an adjuvant, wherein the formulation provides a mean time to maximum plasma concentration of nalmefene of about 2.0 hours or less post an intramuscular administration to a population of healthy subjects.
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A method of providing opioid overdose rescue to a subject comprising intramuscularly or subcutaneously administering to a subject in need thereof a parenteral formulation comprising a therapeutically effective amount of nalmefene or a pharmaceutically acceptable salt thereof and a parenterally acceptable absorption enhancing amount of an adjuvant, wherein the formulation provides a time to onset of opioid antagonistic action of less than 5 minutes post administration via an intramuscular or subcutaneous injection to a subject experiencing an opioid agonist overdose.
A method of preparing a subject prior to entering a locale having a potentially toxic level of an opioid such that the subject is protected from experiencing an opioid overdose as a result of entering the locale, said preparation comprising administering to the subject prior to the subject entering the locale a parenteral formulation comprising a therapeutically effective amount of nalmefene or a pharmaceutically acceptable salt thereof and a parenterally acceptable absorption enhancing amount of an adjuvant, wherein the formulation provides a mean time to maximum plasma concentration of nalmefene of about 2.0 hours or less post an intramuscular administration to a population of healthy subjects.
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Dependencies are inferred from the claim text.