Formulations and methods for the prevention of opioid overdose
AssigneesAegis Therapeutics, LLC, Indivior Inc.
InventorsRoger CRYSTAL, Phil SKOLNICK, Edward T. MAGGIO
Life of this patent
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Abstract
Formulations and methods for the preventative treatment of incidental opioid overdose comprising the intranasal (IN) administration of a pharmaceutical formulation containing the opioid antagonist nalmefene as a prophylactic measure.
Claims71
A method for the prevention (prophylaxis) of opioid overdose or a symptom thereof caused by incidental exposure of a subject to an opioid agonist, comprising nasally administering to a subject in need thereof a pharmaceutical formulation comprising a therapeutically effective amount of nalmefene hydrochloride, a hydrate thereof, or another pharmaceutically acceptable salt of nalmefene.
A pharmaceutical formulation, comprising:
- a. about 2% (w/v) to about 10% (w/v) nalmefene hydrochloride, a hydrate thereof, or another pharmaceutically acceptable salt;
- b. between about 0.2% (w/v) to about 1.2% (w/v) of an isotonicity agent;
- c. between about 0.005% (w/v) to about 0.05% (w/v) of a preservative;
- d. between about 0.1% (w/v) to about 0.5% (w/v) of a stabilizing agent;
- e. between about 0.1% (w/v) to about 0.5% (w/v) of an alkylsaccharide absorption enhancer;
- and
- f. water;
- wherein the pH of the formulation is between about 3.5 and about 5.5.
A method of treating opioid overdose or a symptom thereof in a human subject, comprising the steps of:
- a. providing a pharmaceutical formulation, comprising:
- i. between about 1% (w/v) to about 4% (w/v) nalmefene, or a pharmaceutically acceptable salt, hydrate, or solvate thereof;
- ii. between about 0.05% (w/v) to about 2.5% (w/v) of an alkylsaccharide absorption enhancer;
- iii. water in an amount sufficient to total about 100 microliters of the formulation, wherein the pH of the formulation is between about 3.5 to 5.5;
- and
- b. administering about 100 microliters of the formulation to the subject.
Dependencies are inferred from the claim text.