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Devices and methods for delivering opioid antagonists including formulations for naloxone

  • US 9,517,307 B2
  • Filed: 07/18/2014
  • Issued: 12/13/2016
  • Est. Priority Date: 07/18/2014
  • Status: Active Grant
First Claim
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1. An apparatus, comprising:

  • a housing;

    a medicament container disposed within the housing, the medicament container containing a dose of a naloxone composition, the dose having a delivered volume of at least 0.34 ml;

    a needle configured to move between a first needle position, in which the needle is disposed within the housing, and a second needle position, in which a portion of the needle extends from the housing, the needle configured to be placed in fluid communication with the medicament container when the needle is in the second needle position; and

    an actuation assembly including an energy storage member and a movable member, the energy storage member configured to produce a force on the movable member to move the needle from the first needle position to the second needle position and deliver the dose of the naloxone composition from the medicament container via the needle,when actuated, the actuation assembly delivers the dose of the naloxone composition into a body in less than 0.5 seconds and such that a 90% confidence interval of at least one of a relative mean maximum naloxone plasma concentration after the dose is delivered into the body (Cmax), a time to reach a maximum naloxone plasma concentration (Tmax), an area under a plasma concentration-time curve from pre-dose (time

         0) extrapolated to infinity (AUC0-∞

    ), or an area under a plasma concentration-time curve from pre-dose (time

         0) to a time of a last quantifiable concentration (Tlast) (AUC0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition delivered via a manually-actuated syringe is within 80% to 125%.

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