Drug products for intranasal administration and uses thereof

Abstract

Provided herein are methods of using drug products adapted for nasal delivery comprising a device and a pharmaceutical composition comprising an opioid receptor antagonist, wherein the claimed invention provides a method of treating an opioid overdose or symptom thereof in a patient in need thereof, comprising intranasally administering to the patient an aqueous pharmaceutical solution consisting of, or an aqueous pharmaceutical composition consisting essentially of: (i) naloxone hydrochloride in an amount of about 9% by weight based on the total weight of the aqueous pharmaceutical solution; (ii) glycerin in an amount of about 1.4% by weight based on the total weight of the aqueous pharmaceutical solution; (iii) a citrate buffer system adjusted by hydrochloric acid and/or sodium hydroxide; and (iv) United States Pharmacopeia (USP)—grade Purified Water; wherein the pH of the aqueous pharmaceutical solution is from about 3.5 to about 4.7; and wherein the hydrochloric acid and the sodium hydroxide may each be independently present in the aqueous pharmaceutical solution, as required, to achieve the pH from about 3.5 to about 4.7.