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Devices and methods for delivering opioid antagonists including formulations for naloxone

  • US 10,220,158 B2
  • Filed: 12/07/2016
  • Issued: 03/05/2019
  • 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 be placed in fluid communication with the medicament container when an end portion of the needle is extended outside of the housing; and

    an actuation assembly including an energy storage member configured to produce a force on an elastomeric member within the medicament container to 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 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 the 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 via a manually-actuated syringe is within 80% to 125%.

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