Methods for treating or preventing migraine headache

Abstract

The present invention relates to methods of migraine prophylaxis using anti-CGRP receptor antibodies or binding fragments. In particular, methods for preventing or reducing the occurrence of migraine headache in a patient in need thereof comprising administering to the patient an anti-CGRP receptor or binding fragment according to specific dosage regimens are disclosed. Pharmaceutical compositions and administration devices comprising anti-CGRP receptor antibodies or binding fragments for use in the methods are also described.

What is claimed: 
     
         1 . A pre-filled device for use in prophylactically treating migraine headache comprising a pharmaceutical composition comprising 70 mg or 140 mg of an anti-CGRP receptor monoclonal antibody, an acetate buffer, sucrose, and polysorbate, wherein the anti-CGRP receptor monoclonal antibody comprises a CDRH1 having the sequence of SEQ ID NO:14, a CDRH2 having the sequence of SEQ ID NO:23, a CDRH3 having the sequence of SEQ ID NO:34, a CDRL1 having the sequence of SEQ ID NO:44, a CDRL2 having the sequence of SEQ ID NO:55, and a CDRL3 having the sequence of SEQ ID NO:65, and wherein the injection volume of the device is about 1 ml or less. 
     
     
         2 . The pre-filled device of  claim 1 , wherein the device is adapted to deliver the pharmaceutical composition by subcutaneous injection. 
     
     
         3 . The pre-filled device of  claim 1 , wherein the device is a pre-filled syringe. 
     
     
         4 . The pre-filled device of  claim 1 , wherein the device is an autoinjector. 
     
     
         5 . The pre-filled device of  claim 1 , wherein the polysorbate is polysorbate 20 or polysorbate 80. 
     
     
         6 . The pre-filled device of  claim 5 , wherein the polysorbate is present in the pharmaceutical composition at a concentration of about 0.010% w/v. 
     
     
         7 . The pre-filled device of  claim 1 , wherein the anti-CGRP receptor monoclonal antibody comprises a heavy chain variable region (V H ) comprising the sequence of SEQ ID NO:92, and a light chain variable region (V L ) comprising the sequence of SEQ ID NO:80. 
     
     
         8 . The pre-filled device of  claim 1 , wherein the anti-CGRP receptor monoclonal antibody comprises a heavy chain comprising the sequence of SEQ ID NO:105, and a light chain comprising the sequence of SEQ ID NO:123. 
     
     
         9 . The pre-filled device of  claim 1 , wherein the pharmaceutical composition comprises 70 mg of the anti-CGRP receptor monoclonal antibody. 
     
     
         10 . The pre-filled device of  claim 9 , wherein the injection volume of the device is about 1 ml. 
     
     
         11 . The pre-filled device of  claim 1 , wherein the pharmaceutical composition comprises 140 mg of the anti-CGRP receptor monoclonal antibody. 
     
     
         12 . The pre-filled device of  claim 11 , wherein the injection volume of the device is about 1 ml. 
     
     
         13 . A kit comprising the pre-filled device of  claim 1  and instructions for using the device to administer the pharmaceutical composition by subcutaneous injection to prophylactically treat migraine headache. 
     
     
         14 . The kit of  claim 13 , wherein the pre-filled device is a pre-filled syringe. 
     
     
         15 . The kit of  claim 13 , wherein the pre-filled device is an autoinjector. 
     
     
         16 . The kit of  claim 13 , wherein the injection volume of the device is about 1 ml.