Claims for Patent: 11,458,091

Summary for Patent: 11,458,091

Title:	Compositions and methods for the treatment of opioid overdose
Abstract:	Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising nalmefene are provided. Methods of treating opioid overdose with the drug products are also provided.
Inventor(s):	Roger Crystal, Edward T. Maggio
Assignee:	Indivior Inc, Aegis Therapeutics LLC
Application Number:	US16/461,354
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,458,091
Patent Claims:	1. A pharmaceutical formulation for intranasal administration, comprising: about 3% (w/v) nalmefene hydrochloride; between about 0.1% (w/v) and about 0.5% (w/v) dodecyl maltoside; between about 0.2% (w/v) and about 1.2% (w/v) NaCl between about 0.13% (w/v) and about 0.67% (w/v) disodium edetate; between about 0.001% (w/v) and about 0.1% (w/v) benzalkonium chloride; an amount of an acid or base sufficient to achieve a pH of between 3.5 and 5.5; and water in an amount sufficient to achieve a final volume of about 50 μL to about 200 μL. 2. A pharmaceutical formulation for intranasal administration, comprising: about 3 mg nalmefene hydrochloride or a pharmaceutically acceptable salt, hydrate, or solvate thereof; between about 0.1 mg and about 0.5 mg dodecyl maltoside; between about 0.2 mg and about 1.2 mg NaCl; between about 0.13 mg and about 0.67 mg disodium edetate; between about 0.001 mg and about 0.1 mg benzalkonium chloride; an amount of an acid or base sufficient to achieve a pH of between 3.5 and 5.5; and water in an amount sufficient to achieve a final volume of about 100 μL. 3. The pharmaceutical formulation as recited in claim 1, comprising about 0.25% (w/v) dodecyl maltoside. 4. A device adapted for nasal delivery of a pharmaceutical formulation to a patient by actuation of the device into a nostril of the patient, the device comprising a pharmaceutical formulation as recited in claim 1. 5. A method of treating opioid overdose for at least 3 hours in a patient in need thereof, comprising nasally administering to the patient, a pharmaceutical formulation as recited in claim 1, thereby treating opioid overdose in the patient. 6. The pharmaceutical formulation as recited in claim 2, comprising about 3 mg nalmefene hydrochloride or a hydrate thereof. 7. The pharmaceutical formulation as recited in claim 2, wherein upon the administration to a human subject of about 3 mg of nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof, the Tmax is 20 minutes or less. 8. The pharmaceutical formulation as recited in claim 2, wherein upon the administration to a human subject of about 3 mg of nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof, the Tmax is 15 minutes or less. 9. The pharmaceutical formulation as recited in claim 2, wherein upon the administration to a human subject of about 3 mg of nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof, the Tmax after administration of the composition is lower than the Tmax of an intranasal formulation of about 3 mg nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof that does not contain dodecyl maltoside. 10. The pharmaceutical formulation as recited in claim 2, wherein upon the administration to a human subject of about 3 mg of nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof, the Tmax after administration of the composition is at least about 85% lower than the Tmax of an intranasal formulation of about 3 mg nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof that does not contain dodecyl maltoside. 11. The pharmaceutical formulation as recited in claim 2, wherein upon administration to a human subject of about 3 mg of the nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof, the Tmax after administration of the composition is about 80% to about 90% lower than the Tmax of an intranasal formulation of about 3 mg nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof that does not contain dodecyl maltoside. 12. The pharmaceutical formulation as recited in claim 2, wherein upon administration to a human subject of about 3 mg of the nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof, the Cmax after administration of the composition is at least about 2 times higher than the Cmax of an intranasal formulation of about 3 mg nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof that does not contain dodecyl maltoside. 13. The pharmaceutical formulation as recited in claim as recited in claim 2, wherein upon the administration to a population of human subjects of about 3 mg of nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof, the mean concentration of nalmefene at about 5 minutes post-dose is about 1 ng/mL. 14. The pharmaceutical formulation as recited in claim as recited in claim 2, wherein upon the administration to a population of human subjects of about 3 mg of nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof, the mean concentration of nalmefene at about 15 minutes post-dose is about 4 ng/mL. 15. The pharmaceutical formulation as recited in claim as recited in claim 2, wherein upon the administration to a population of human subjects of about 3 mg of nalmefene or a pharmaceutically acceptable salt, hydrate, or solvate thereof, the mean concentration of nalmefene at about 30 minutes post-dose is about 3 ng/mL.