Claims for Patent: 9,517,307

Summary for Patent: 9,517,307

Title:	Devices and methods for delivering opioid antagonists including formulations for naloxone
Abstract:	An apparatus includes a container, a needle, and an actuation assembly. The container contains a dose of a naloxone composition having a delivered volume of at least about 0.34 mL. The actuation assembly includes an energy storage member that produces a force on a movable member to move the needle and to deliver the dose of the naloxone composition. The 90% confidence interval of at least one of the relative mean maximum naloxone plasma concentration after dose delivery into the body (C.sub.max), time to reach the maximum naloxone plasma concentration (T.sub.max), area under the plasma concentration-time curve from pre-dose (time 0) extrapolated to infinity (AUC.sub.0-.infin.), or area under the plasma concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (T.sub.last) (AUC.sub.0-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%.
Inventor(s):	Blondino; Frank E. (Henrico, VA), Edwards; Eric S. (Moseley, VA), Edwards; Evan T. (Charlottesville, VA), Kelley; Glen L. (Glen Allen, VA), Meyers; Paul F. (Fishers, IN)
Assignee:	kaleo, Inc. (Richmond, VA)
Application Number:	14/335,490
Patent Claims:	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 (C.sub.max), a time to reach a maximum naloxone plasma concentration (T.sub.max), an area under a plasma concentration-time curve from pre-dose (time 0) extrapolated to infinity (AUC.sub.0-.infin.), or an area under a plasma concentration-time curve from pre-dose (time 0) to a time of a last quantifiable concentration (T.sub.last) (AUC.sub.0-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%. 2. The apparatus of claim 1, wherein the force delivered by the actuation assembly on the movable member decreases during delivery of the dose from a start force to an end force. 3. The apparatus of claim 1, wherein the force delivered by the actuation assembly on the movable member decreases during delivery of the dose from a start force to an end force, the start force being between 30 pounds and 38 pounds, the end force being between 23 pounds and 31 pounds. 4. The apparatus of claim 1, wherein when the actuation assembly is actuated, a pressure produced within the medicament container by the movable member decreases during delivery of the dose from a start pressure to an end pressure, the start pressure being between 525 pounds per square inch and 670 pounds per square inch, the end pressure being between 400 pounds per square inch and 545 pounds per square inch. 5. The apparatus of claim 1, further comprising: a retraction mechanism configured to produce a retraction force to move the needle from the second needle position towards the first needle position after delivery of the dose. 6. The apparatus of claim 1, further comprising: a retraction mechanism configured to produce a retraction force of 5 pounds to move the needle from the second needle position towards the first needle position after delivery of the dose. 7. The apparatus of claim 1, further comprising: a retraction spring configured to urge the needle towards the first needle position; and a release member, the movable member configured to interface with the release member after delivery of the dose to release the force from the movable member, the actuation assembly and the release member configured such that 0.4 ml of the naloxone composition is delivered before the needle begins movement from the second needle position towards the first needle position. 8. The apparatus of claim 1, wherein the delivered volume is 0.4 ml. 9. The apparatus of claim 1, wherein the delivered volume is between 0.34 ml and 0.46 ml. 10. The apparatus of claim 1, wherein the delivered volume is between 0.34 ml and 2 ml. 11. The apparatus of claim 1, wherein the amount of the dose is 0.4 mg. 12. The apparatus of claim 1, wherein the amount of the dose is between 0.4 mg and 1 mg. 13. The apparatus of claim 1, wherein the amount of the dose is between 0.4 mg and 2 mg. 14. The apparatus of claim 1, wherein the amount of the dose is between 0.4 mg and 10 mg. 15. The apparatus of claim 1, wherein the energy storage member is a compressed gas container having an initial container pressure of 1100 pounds per square inch. 16. The apparatus of claim 1, wherein when actuated, the actuation assembly delivers the dose of the naloxone composition into the body such that the 90% confidence interval of the relative mean C.sub.max of a delivered dose to the delivered dose of the corresponding naloxone composition delivered via the manually-actuated syringe is within 100% to 125%. 17. The apparatus of claim 1, wherein the needle has an exposed needle length of 0.5 between 0.49 inches and 0.51 inches when the needle is in the second needle position. 18. A method, comprising: placing a medicament injector against a body, the medicament injector including: 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 and a second needle position, a portion of the needle extending from the housing when the needle is in the second needle position, 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; and actuating the medicament injector such that the energy storage member produces 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 into the body in less than 0.5 seconds and in a manner 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 (C.sub.max), a time to reach a maximum naloxone plasma concentration (T.sub.max), an area under a plasma concentration-time curve from pre-dose (time 0) extrapolated to infinity (AUC.sub.0-.infin.), or an area under the plasma concentration-time curve from pre-dose (time 0) to a time of a last quantifiable concentration (T.sub.last) (AUC.sub.0-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%. 19. The method of claim 18, wherein the actuating includes pressing a distal end portion of the housing against the body. 20. The method of claim 18, wherein the portion of the needle has a length of 0.5 between 0.49 inches and 0.51 inches.