Reduced Volume Formulation of Glatiramer Acetate and Methods of Administration

Abstract

A method for reducing frequency of relapses in a human patient afflicted with relapsing-remitting multiple sclerosis (RRMS) comprising administering to the patient 0.5 ml of an aqueous pharmaceutical solution of 20 mg glatiramer acetate and 20 mg mannitol.

1 - 20 . (canceled) 
     
     
         21 . An injection assisting device comprising:
 a first outer shell having a first internal cavity with first and second oppositely arranged openings and   a second outer shell movably and removably connectable to the first outer shell, the second outer shell having a second internal cavity with at least a first opening oriented towards the second opening of the first outer shell;   a button configured to initiate an injection;   an injection locking member configured to prevent the initiation of an injection in the absence of a predetermined compressive force between the second assembly and the first assembly;   an injection energy storing member configured to absorb and retain a predetermined amount of injection energy applied to a syringe located within at least one of the first and second cavities during an injection;   an injection actuator configured, upon the initiation of an injection, to apply the injection energy to the syringe so as to displace a predetermined amount of matter from within the syringe;   an injection completion indicator inside an indicator window, configured to indicate to a user when the predetermined amount of matter has been displaced from within the syringe; and   an injection lock indicator outside of the indicator window, configured to indicate to a user whether the injection locking member is in a locked state, and configured to substantially contrast with a color of both of the first outer shell and the second outer shell, and configured to be substantially shielded from a view of a user in the presence of the predetermined amount of compression force between the second outer shell and the first outer shell.   
     
     
         22 . The injection assisting device of  claim 21 , further comprising an attention director configured to direct a user's attention to the injection completion indicator. 
     
     
         23 . The injection assisting device of  claim 21 , further comprising an injection force storage indicator configured to indicate to a user whether at least the predetermined amount of injection energy is stored in the injection energy storing member. 
     
     
         24 . The injection assisting device of  claim 21 , further comprising an outer grip member disposed on an outer surface of the second outer shell. 
     
     
         25 . The injection assisting device of  claim 24 , wherein the outer grip member is formed of a material softer than the second outer shell. 
     
     
         26 . The injection assisting device of  claim 24 , wherein ridges exist in an outer surface of the outer grip member so as to increase friction between the outer grip member and a human hand. 
     
     
         27 . The injection assisting device of  claim 21 , further comprising a ring member between the first outer shell and the second outer shell configured to substantially contrast with a color of the first outer shell, a color of the second outer shell, or a color of the injection lock indicator. 
     
     
         28 . The injection assisting device of  claim 22 , wherein the attention director is configured to direct a user's attention to the direction of the injection. 
     
     
         29 . The injection assisting device of  claim 22 , wherein the attention director is configured to direct a user's attention to the injection lock indicator. 
     
     
         30 . The injection assisting device of  claim 22 , wherein the attention director is configured to direct a user's attention to the direction of force to be applied to unlock the locking member. 
     
     
         31 . The injection assisting device of  claim 22 , wherein:
 a color of the attention director is configured to substantially contrast with a color of proximally located components, and   a shape of the attention director is configured to direct a user's attention to the injection completion indicator.   
     
     
         32 . The injection assisting device of  claim 21 , further comprising a needle penetration depth adjustment member and a syringe needle cap remover member. 
     
     
         33 . The injection assisting device of  claim 32 , wherein the syringe needle cap remover member is configured to substantially correspond in color with the button configured to initiate an injection. 
     
     
         34 . The injection assisting device of  claim 21 , wherein the injection actuator is configured to displace 0.5 ml of liquid from the syringe. 
     
     
         35 . The injection assisting device of  claim 34 , wherein the syringe contains in a 0.5 ml solution 20 mg of glatiramer acetate. 
     
     
         36 . The injection assisting device of  claim 22 , wherein the injection actuator is configured to displace 0.5 ml of liquid from the syringe. 
     
     
         37 . The injection assisting device of  claim 36 , wherein the syringe contains in a 0.5 ml solution 20 mg of glatiramer acetate. 
     
     
         38 . The injection assisting device of  claim 31 , wherein the injection actuator is configured to displace 0.5 ml of liquid from the syringe. 
     
     
         39 . The injection assisting device of  claim 38 , wherein the syringe contains in a 0.5 ml solution 20 mg of glatiramer acetate. 
     
     
         40 . The injection assisting device of  claim 33 , wherein the injection actuator is configured to displace 0.5 ml of liquid from the syringe. 
     
     
         41 . The injection assisting device of  claim 40 , wherein the syringe contains in a 0.5 ml solution 20 mg of glatiramer acetate.