Methods of treating fibromyalgia
The invention relates to an anti-CGRP antibody for use in the prevention and/or treatment of chronic pain and/or symptoms of chronic pain, and to a method of treating and/or preventing chronic pain and/or symptoms of chronic pain using an anti-CGRP antibody.
1. A method of treatment of fibromyalgia and/or symptoms of fibromyalgia in an individual, the method comprising administering to the individual a therapeutically effective amount of an anti-CGRP antagonist antibody, wherein the anti-CGRP antagonist antibody comprises the following complementarity determining regions (CDRs):
(a) CDR H1 as set forth in SEQ ID NO: 3;
(b) CDR H2 as set forth in SEQ ID NO: 4;
(c) CDR H3 as set forth in SEQ ID NO: 5;
(d) CDR L1 as set forth in SEQ ID NO: 6;
(e) CDR L2 as set forth in SEQ ID NO: 7; and
(f) CDR L3 as set forth in SEQ ID NO: 8.
2. The method according to claim 1 , wherein the anti-CGRP antagonist antibody is administered peripherally.
3. The method according to claim 1 , wherein the anti-CGRP antagonist antibody is administered subcutaneously or intravenously.
4. The method according to claim 1 , wherein the anti-CGRP antagonist antibody acts peripherally on administration.
5. The method according to claim 1 , wherein the anti-CGRP antagonist antibody:
(i) is a human antibody,
(ii) is a humanized antibody,
(iii) is a monoclonal antibody,
(iv) binds CGRP with a Kd of 50 nM or less (as measured by surface plasmon resonance at 37° C.); and/or
(v) has a half-life in-vivo of at least 7 days.
6. The method according to claim 1 , wherein the anti-CGRP antibody comprises a VH domain that is at least 90% identical in amino acid sequence to SEQ ID NO: 1.
7. The method according to claim 1 , wherein the anti-CGRP antibody comprises a VL domain that is at least 90% identical in amino acid sequence to SEQ ID NO: 2.
8. The method according to claim 1 , wherein the anti-CGRP antibody comprises a VH domain that is at least 90% identical in amino acid sequence to SEQ ID NO: 1 and a VL domain that is at least 90% identical in amino acid sequence to SEQ ID NO: 2.
9. The method according to claim 1 , wherein the anti-CGRP antibody comprises a heavy chain produced by the expression vector with ATCC Accession No. PTA-6867.
10. The method according to claim 1 , wherein the anti-CGRP antibody comprises a light chain produced by the expression vector with ATCC Accession No. PTA-6866.
11. The method according to claim 1 , wherein the anti-CGRP antibody is produced by the expression vectors with ATCC Accession Nos. PTA-6867 and PTA-6866.
12. The method according to claim 1 , wherein the anti-CGRP antagonist antibody is administered by subcutaneous or intravenous injection one time per month.
13. The method according to claim 1 , wherein the anti-CGRP antagonist antibody does not produce CNS impairment of motor coordination or attention.
14. The method according to claim 1 , wherein the anti-CGRP antagonist antibody is not administered centrally, spinally or intrathecally.
15. The method according to claim 1 , wherein the anti-CGRP antagonist antibody is not a centrally, spinally or intrathecal penetrating molecule.
16. The method according to claim 1 , wherein the anti-CGRP antibody is administered separately, sequentially or simultaneously in combination with one or more further pharmacologically active compounds.
17. The method according to claim 16 , wherein the one or more further pharmacologically active compounds is/are selected from;
(i) an opioid analgesic;
(ii) a nonsteroidal antiinflammatory drug;
(iii) a barbiturate sedative;
(iv) a benzodiazepine having a sedative action;
(v) an H 1 antagonist having a sedative action;
(vi) a sedative;
(vii) a skeletal muscle relaxant;
(viii) an NMDA receptor antagonist;
(ix) an alpha-adrenergic;
(x) a tricyclic antidepressant;
(xi) an anticonvulsant;
(xii) a tachykinin antagonist;
(xiii) a muscarinic antagonist;
(xiv) a COX-2 inhibitor;
(xv) a non-selective COX inhibitor;
(xvi) a coal-tar analgesic;
(xvii) a neuroleptic;
(xviii) a vanilloid receptor agonist;
(xix) a beta-adrenergic;
(xx) a local anaesthetic;
(xxi) a corticosteroid;
(xxii) a serotonin receptor agonist or antagonist;
(xxiii) a cholinergic analgesic;
(xxiv) Tramadol;
(xxv) a PDEV inhibitor;
(xxvi) an alpha-2-delta ligand; and
(xxvii) a canabinoid.
18. The method of claim 17 , wherein the corticosteroid is dexamethasone.