Intranasal administration of ketamine to cluster headache patients

Abstract

Provided is a method of treating patients with cluster headache comprising intranasal administration to a patient in need thereof of an aqueous composition, e.g., pharmaceutical composition, comprising a therapeutically effective amount of ketamine, a method of reducing or eliminating side effects of ketamine when used in the treatment of Cluster headache, and to a composition, e.g., pharmaceutical composition, comprising a therapeutically effective amount of ketamine for use in the treatment of cluster headache, wherein the composition is in a nasal dosage form such as a nasal spray.

1 . (canceled) 
     
     
         2 . A method of treating a patient having a cluster headache comprising intranasally administering to said patient an amount of ketamine in a range of from 5 mg to about 15 mg. 
     
     
         3 . The method according to  claim 2 , wherein the cluster headache is in the form of a chronic cluster headache or in the form of an episodic cluster headache. 
     
     
         4 . The method according to  claim 2 , wherein the ketamine is (R,S)-ketamine hydrochloride. 
     
     
         5 . The method according to  claim 2 , wherein the ketamine is S-ketamine hydrochloride. 
     
     
         6 . The method according to  claim 2 , wherein the amount of ketamine administered is from 5 mg to 10 mg of ketamine base (2-(2-chlorophenyl)- 2-(methylamino)cyclohexanone). 
     
     
         7 . The method according to  claim 2 , wherein the composition comprising ketamine is administered in an amount resulting in a systemic absorbed dose essentially corresponding to or lower than the absorbed dose resulting from intravenous (IV) administration, whereby side effects of ketamine when used in the treatment of cluster headache are reduced or eliminated. 
     
     
         8 . The method according to  claim 2 , wherein ketamine is administered in the form of an aqueous solution, wherein the concentration of ketamine is in a range of from 50 mg/mL to 200 mg/mL. 
     
     
         9 . The method according to  claim 2 , wherein ketamine is administered in the form of an aqueous solution having a pH in a range of from 4.0 to 6.5. 
     
     
         10 . The method according to  claim 2 , wherein ketamine is administered by a nasal spray in one or more unit doses. 
     
     
         11 . The method according to  claim 8 , wherein ketamine is administered by a nasal spray in one or more unit doses.