Claims for Patent: 10,143,792

Summary for Patent: 10,143,792

Title:	Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Abstract:	Medicament delivery devices for administration of opioid antagonists are described herein. In some embodiments, an apparatus includes a housing, a medicament container disposed within the housing and an energy storage member disposed within the housing. The medicament container is filled with a naloxone composition that includes naloxone or salts thereof, a tonicity-adjusting agent, and a pH adjusting agent, whereby the osmolality of the naloxone composition ranges from about 250-350 mOsm and the pH ranges from about 3-5. The energy storage member is configured to produce a force to deliver the naloxone composition.
Inventor(s):	Edwards; Eric S. (Moseley, VA), Edwards; Evan T. (Charlottesville, VA), Licata; Mark J. (Doswell, VA), Blondino; Frank E. (Henrico, VA)
Assignee:	kaleo, Inc. (Richmond, VA)
Application Number:	15/331,073
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,143,792
Patent Claims:	1. A method, comprising: removing a medicament delivery device containing a naloxone composition from a case, the medicament delivery device including a housing, a medicament container, and a delivery member, the medicament container disposed within the housing and defining an internal volume containing the naloxone composition, the naloxone composition including a tonicity-adjusting agent, the pH of the naloxone composition ranging from 3 to 5, the delivery member coupled to the medicament container before the removing; receiving an instruction associated with a use of the medicament delivery device; and actuating the medicament delivery device to (1) cause the medicament container to move distally within the housing to place the delivery member in fluid communication with the internal volume of the medicament container and (2) convey a single dose of the naloxone composition from the internal volume via the delivery member. 2. The method of claim 1, wherein: the medicament delivery device is an auto-injector; and the delivery member is a needle, the needle being coupled to the medicament container via a coupling member, the needle being fluidically isolated from the internal volume when the coupling member and the medicament container are in a first configuration, the needle in fluid communication with the internal volume when the coupling member and the medicament container are in a second configuration. 3. The method of claim 1, wherein: the medicament delivery device is an intranasal spray device; and the delivery member is associated with an atomizer defining an orifice through which the naloxone composition is delivered, the atomizer being coupled to the medicament container via a coupling member, the coupling member including a needle, the coupling member and the medicament container being in a first configuration prior to the medicament delivery device being removed from the case, an end portion of the needle being disposed outside of the internal volume when the coupling member and the medicament container are in the first configuration, the end portion of the needle disposed within the internal volume when the coupling member and the medicament container are in a second configuration. 4. The method of claim 1; further comprising: storing, before the removing, the medicament delivery device within the case for at least six months. 5. The method of claim 1, further comprising: sending a wireless signal in response to the removing the medicament delivery device from the case. 6. The method of claim 1, wherein the instruction is a written instruction coupled to at least one of the case or the medicament delivery device. 7. The method of claim 1, wherein the instruction is a recorded speech output produced by at least one of the case or the medicament delivery device. 8. The method of claim 1, wherein: the medicament delivery device is stored within the case for at least six months before the removing; and the actuating the medicament delivery device causes movement of an elastomeric member within the medicament container to convey the single dose of the naloxone composition from the internal volume, the elastomeric member including a silicone-based material. 9. The method of claim 1, wherein: the tonicity-adjusting agent includes sodium chloride in an amount such that a concentration of sodium chloride is between 0.1 mg/mL and 20 ng/mL. 10. The method of claim 1, wherein the medicament delivery device is a medical injector and the delivery member is a needle covered by a needle sheath, the method further comprising: removing, before the actuating, a safety lock coupled to a distal end portion of the housing, the safety lock including an engagement portion that engages the needle sheath and removes the needle sheath from about the needle in response to the removing the safety lock. 11. The method of claim 1, wherein: the actuating the medicament delivery device includes placing, by a first person, a distal end portion of the housing against a target location of a second person, the instructions received by the first person, the single dose of the naloxone composition conveyed to the target location of the second person. 12. The method of claim 1, wherein the naloxone composition includes 4,5-epoxy-3,14-di hydroxy-17-(2-propenyl)morphinan-6-one in a concentration of between about 0.01 mg/mL and about 60 mg/mL. 13. The method of claim 12, wherein the concentration of the 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one is about 10 mg/mL. 14. The method of claim 12, wherein the single dose of the naloxone composition conveyed from the internal volume contains between 3 mg and 24 mg of the naloxone composition. 15. The method of claim 14, wherein the single dose of the naloxone composition conveyed from the internal volume contains between 4 mg and 18 mg of the naloxone composition. 16. A method of delivering a single dose of a naloxone composition to a patient, comprising: removing a medical injector containing the naloxone composition from a case, the medical injector including a housing, a prefilled medicament container assembly, and a needle, the prefilled medicament container assembly disposed within the housing and including a container body, the naloxone composition contained within the container body, and an elastomeric member that seals the naloxone composition within the container body, the naloxone composition including a tonicity-adjusting agent and a pH adjusting agent, the pH of the naloxone composition ranging from 3 to 5, the needle coupled to the prefilled medicament container assembly before the removing; receiving an instruction associated with a use of the medical injector; placing a portion of the medical injector into contact with the patient; and actuating the medical injector to cause the elastomeric member to move within the container body to convey the single dose of the naloxone composition from the container body via the needle. 17. The method of claim 16, wherein the actuating includes moving an actuator coupled to an end portion of the housing to cause a force to be applied to a rod that moves the elastomeric member within the container body. 18. The method of claim 16, wherein the prefilled medicament container assembly is a prefilled syringe. 19. The method of claim 16, wherein: the medical injector is stored within the case for at least six months before the removing; and the elastomeric member includes a silicone-based material. 20. The method of claim 16, wherein the elastomeric member is formulated to be compatible with the naloxone composition when in contact with the naloxone composition for a time period of at least two years. 21. The method of claim 20, wherein the elastomeric member is formulated to include a polymer and a curing agent, the polymer including at least one of bromobutyl or chlorobutyl, the curing agent including at least one of sulfur or a metal oxide. 22. The method of claim 16, wherein: the pH of the naloxone composition ranges from about 3.2-3.6; the tonicity-adjusting agent includes at least one of dextrose, glycerin, mannitol, potassium chloride or sodium chloride; and the elastomeric member includes a polymer and a curing agent, the elastomeric member is formulated to be compatible with the naloxone composition when in contact with the naloxone composition for a time period of at least two years. 23. The method of claim 16, wherein the naloxone composition includes 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one in a concentration of between about 0.01 mg/mL and about 60 mg/mL. 24. The method of claim 23, wherein the concentration of the 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one is about 10 mg/mL. 25. The method of claim 23, wherein the single dose of the naloxone composition conveyed from the internal volume contains between 3 mg and 24 rig of the naloxone composition. 26. The method of claim 25, wherein the single dose of the naloxone composition conveyed from the internal volume contains between mg and 18 mg of the naloxone composition.