Nasal drug products and methods of their use

Abstract

Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.

What is claimed is: 
     
         1 . A prefilled nasal delivery device comprising:
 a reservoir containing a pharmaceutical composition comprising naloxone hydrochloride, an amount of water sufficient to achieve a therapeutically effective amount of about 8 mg naloxone hydrochloride per 100 μL, an amount of hydrochloric acid sufficient to achieve a pH of 3.5-5.5, and propylene glycol, and;   wherein the device is configured to deliver the therapeutically effective amount of about 8 mg naloxone hydrochloride or an equivalent thereof in a single use device to a patient suffering from or suspected to be suffering from opioid overdose, without the need for a caregiver to prime the device.   
     
     
         2 . The prefilled nasal delivery device of  claim 1 , wherein the pharmaceutical composition further comprises disodium edetate. 
     
     
         3 . The prefilled nasal delivery device of  claim 1 , wherein the pharmaceutical composition further comprises an alcohol. 
     
     
         4 . The prefilled nasal delivery device of  claim 1 , wherein naloxone hydrochloride is the only pharmaceutically active compound in the pharmaceutical composition. 
     
     
         5 . The prefilled nasal delivery device of  claim 1 , wherein the pharmaceutical composition is storage stable. 
     
     
         6 . The prefilled nasal delivery device of  claim 1 , wherein the patient is a human. 
     
     
         7 . The prefilled nasal delivery device of  claim 1 , wherein the pharmaceutical composition provides a maximum observed plasma concentration of naloxone after administration (C max ) of about 9.52 ng/ml to about 10.9 ng/ml after delivery to the patient. 
     
     
         8 . The prefilled nasal delivery device of  claim 1 , wherein the pharmaceutical composition provides a C max  of about 10.3 ng/ml of naloxone after delivery to the patient. 
     
     
         9 . The prefilled nasal delivery device of  claim 1 , wherein a plasma concentration versus time curve of naloxone in the patient has a T max  of 0.33 hours or less after delivery of the pharmaceutical composition to the patient. 
     
     
         10 . The prefilled nasal delivery device of  claim 1 , wherein the plasma concentration versus time curve of naloxone in the patient has a T max  of less than 20 minutes after delivery of the pharmaceutical composition to the patient. 
     
     
         11 . The prefilled nasal delivery device of  claim 1 , wherein the plasma concentration versus time curve of naloxone in the patient has a T max  of less than 19 minutes after delivery of the pharmaceutical composition to the patient. 
     
     
         12 . The prefilled nasal delivery device of  claim 1 , wherein the plasma concentration versus time curve of naloxone in the patient has a T max  of less than 18.5 minutes after delivery of the pharmaceutical composition to the patient. 
     
     
         13 . The prefilled nasal delivery device of  claim 1 , wherein the pharmaceutical composition has an area under the drug plasma concentration-time curve AUC 0-∞  of about 15.0 ng*mL/h to about 16.9 ng*mL/h of naloxone after delivery of the pharmaceutical composition to the patient.