COMPOSITIONS, DEVICES AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising naltrexone are provided. Formulations and methods of treating alcohol use disorder and related conditions with the drug products are also provided.
1 . A method of treatment of alcohol use disorder in a subject, comprising administering to the subject an intranasal formulation comprising an aqueous solution having:
a) about 1 mg to about 4 mg naltrexone or a salt or hydrate thereof;
b) about 0.05% to about 2.5% of Intravail® (dodecyl maltoside); and
c) one or more excipients selected from sodium chloride, benzalkonium chloride, edetate disodium, and an acid.
2 - 11 . (canceled)
12 . The method as recited in claim 1 , wherein each dose of the intranasal formulation comprises about 3 mg naltrexone or a salt or hydrate thereof.
13 . The method as recited in claim 12 , wherein about 0.05 to about 0.2 mL of said intranasal formulation is delivered to the subject.
14 . The method as recited in claim 13 , wherein about 0.1 mL of said intranasal formulation is delivered to the subject.
15 . The method as recited in claim 13 , wherein said intranasal formulation is at a concentration of 30 mg/mL.
16 . The method as recited in claim 1 , wherein the intranasal formulation is administered as a single administration to one nostril.
17 . The method as recited in claim 1 , wherein the intranasal formulation is administered as two administrations, one to each nostril.
18 . The method as recited in claim 15 wherein the intranasal formulation additionally comprises about 0.1% to about 0.5% of dodecyl maltoside.
19 - 24 . (canceled)
25 . The method as recited in claim 18 , wherein the intranasal formulation comprises about 0.25% of Intravail® (dodecyl maltoside).
26 . The method as recited in claim 1 , wherein the intranasal formulation comprising naltrexone is administered prior to ingestion of alcohol.
27 - 31 . (canceled)
32 . The method as recited in claim 1 , wherein the intranasal formulation is administered in doses of about 3 mg throughout the day as needed by the subject.
33 . The method as recited in claim 32 , wherein the intranasal formulation therapeutically effective amount of naltrexone is administered as a first dose of about 3 mg in the morning, and subsequent doses of about 3 mg as needed prior to consumption of alcohol.
34 - 36 . (canceled)
37 . A pharmaceutical formulation for intranasal administration, formulated as an aqueous solution, comprising:
a) about 1 mg to about 4 mg naltrexone or a salt or hydrate thereof;
b) about 0.05% to about 2.5% of Intravail® (dodecyl maltoside); and
c) one or more excipients selected from sodium chloride, benzalkonium chloride, edetate disodium, and an acid.
38 - 41 . (canceled)
42 . The pharmaceutical formulation as recited in claim 37 , wherein about 0.1 mL of said formulation is delivered to the subject.
43 - 48 . (canceled)
49 . The pharmaceutical formulation as recited in claim 42 , wherein the intranasal formulation comprises between about 0.1% to about 0.5% of Intravail® (dodecyl maltoside).
50 . The pharmaceutical formulation as recited in claim 49 , wherein the intranasal formulation comprises about 0.25% of Intravail® (dodecyl maltoside).
51 - 55 . (canceled)
56 . A multi-dose device adapted for nasal delivery of a pharmaceutical formulation to a subject suffering alcohol use disorder, comprising a plurality of doses each having the formulation as recited in claim 1 .
57 . The device as recited in claim 56 , further comprising a dose counter.
58 - 63 . (canceled)
64 . The device as recited in claim 57 , comprising about 3 mg naltrexone or a salt or hydrate thereof in each dose.
65 . The device as recited in claim 56 , wherein about 0.05 to about 0.2 mL of said formulation is delivered to the subject in each dose.
66 . The device as recited in claim 65 , wherein about 0.1 mL of said formulation is delivered to the subject in each dose.
67 - 80 . (canceled)