US2011183936A1PendingUtilityA1

Regimens for intra-articular viscosupplementation

43
Assignee: GENZYME CORPPriority: Dec 30, 2004Filed: Apr 5, 2011Published: Jul 28, 2011
Est. expiryDec 30, 2024(expired)· nominal 20-yr term from priority
Inventors:François Bailleul
A61P 35/00A61P 5/44A61P 31/12A61P 25/04A61P 29/00A61P 25/00A61P 19/02A61P 19/08A61P 19/00A61P 23/00A61K 31/728A61K 9/0024
43
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Claims

Abstract

The invention provides viscosupplementation methods for treating osteoarthritis and joint injury with HA-based viscosupplements, particularly viscosupplements with an intra-articular residence half-life shorter than 3 weeks. Viscosupplements for use in the methods of the invention may be further characterized in that they contain less than 20 mg/ml HA, at least 5% (w/w) of which is in a gel form, such as, e.g., hylan B. In an illustrative embodiment, hylan G-F 20 (Synvisc®) is administered in a single intra-articular knee injection of 6±2 ml.

Claims

exact text as granted — not AI-modified
1 . A method for treating a hip joint of a subject suffering from osteoarthritis in said joint, the method comprising a treatment regimen, the regimen being characterized by the step of administering a single administration dose, within a 24 hour period, of a viscosupplement intra-articularly into the hip joint of said subject,
 wherein said viscosupplement administered in a single administration dose:
 is a hyaluronan (HA) based viscosupplement that does not contain additional active components; and 
 comprises between 24 mg to 100 mg of HA, and 
 comprises a crosslinked hyaluronan (HA), and 
 has a residence half-life in said hip joint of between 0.2 days to 8.8 days; and 
   wherein said treatment regimen does not comprise administering the viscosupplement in weekly intervals.   
     
     
         2 . (canceled) 
     
     
         3 . The method of  claim 1 , wherein the subject is human. 
     
     
         4 . (canceled) 
     
     
         5 . (canceled) 
     
     
         6 . The method of  claim 1 ,  25  or  29 , wherein the subject is in need of treatment of joint pain. 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . The method of  claim 1 ,  25  or  29 , wherein the viscosupplement comprises 8±2 mg/ml HA. 
     
     
         11 . The method of  claim 1 , wherein said HA is of animal origin. 
     
     
         12 . The method of  claim 11 , wherein said HA is produced from rooster combs. 
     
     
         13 . The method of  claim 1 , wherein the said HA is of bacterial origin. 
     
     
         14 . (canceled) 
     
     
         15 . The method of  claim 1 ,  25  or  29 , wherein said viscosupplement comprises HA crosslinked with formaldehyde. 
     
     
         16 . The method of  claim 1 , wherein said viscosupplement comprises hylan A. 
     
     
         17 . The method of  claim 15 , wherein the average molecular weight of said HA crosslinked with formaldehyde is 6,000 kDa. 
     
     
         18 . The method of  claim 1 , wherein said viscosupplement comprises HA crosslinked with divinyl sulfone. 
     
     
         19 . The method of  claim 1 , wherein said viscosupplement comprises hylan B. 
     
     
         20 . The method of  claim 1 , wherein the viscosupplement comprises hylan A and hylan B. 
     
     
         21 . The method of  claim 20 , wherein the ratio of hylan A/hylan B is 9/1 by weight of HA. 
     
     
         22 . The method of  claim 1 ,  25  or  29 , wherein the viscosupplement comprises 8±2 mg/ml of HA, wherein 10% of said HA by weight of HA is in a gel form. 
     
     
         23 . The method of  claim 1 ,  25  or  29 , wherein the viscosupplement is hylan G-F 20. 
     
     
         24 . (canceled) 
     
     
         25 . A method for treating a hip joint of a human subject suffering from a joint pathology, the method comprising a treatment regimen, the regimen being characterized by the step of administering a single administration dose, within a 24 hour period, of a viscosupplement intra-articularly into the hip joint of said human subject,
 wherein said viscosupplement administered in a single administration dose:
 is a hyaluronan (HA) based viscosupplement that does not contain additional active components; and 
 comprises between 24 mg to 100 mg of HA, and 
 comprises a crosslinked hyaluronan (HA), and 
 has a residence half-life in said hip joint of between 0.2 days to 8.8 days; and 
   wherein said treatment regimen does not comprise administering the viscosupplement in weekly intervals.   
     
     
         26 . (canceled) 
     
     
         27 . (canceled) 
     
     
         28 . The method of  claim 25 , wherein the joint pathology is associated with osteoarthritis. 
     
     
         29 . A method for treating osteoarthritic pain in a hip joint of a human subject, the method comprising a treatment regimen, the regimen being characterized by the step of administering a single administration, within a 24 hour period, dose of a viscosupplement intra-articularly into the hip joint of said human subject,
 wherein said viscosupplement administered in a single administration dose:
 is a hyaluronan (HA) based viscosupplement that does not contain additional active components; and 
 comprises between 24 mg to 100 mg of HA, and 
 comprises a crosslinked hyaluronan (HA), and 
 has a residence half-life in said hip joint of between 0.2 days to 8.8 days; and 
   wherein said treatment regimen does not comprise administering the viscosupplement in weekly intervals.   
     
     
         30 - 35 . (canceled) 
     
     
         36 . The method of  claim 1 ,  25  or  29 , wherein 10% of said HA by weight of HA is in a gel form. 
     
     
         37 . The method of  claim 1 ,  25 , or  29  wherein said single administration dose consists of a single injection or multiple injections of said viscosupplement. 
     
     
         38 . The method of  claim 1 ,  25 , or  29  wherein said single administration dose consists of a single injection of said viscosupplement. 
     
     
         39 . The method of  claim 1 ,  25  or  29 , wherein a therapeutic effect is assessed by: a) measuring an improvement in a degree of functional impairment of said hip joint; b) measuring a reduction in joint pain in said hip joint; or c) a global status assessment. 
     
     
         40 . The method of  claim 15 , wherein at least part of said HA crosslinked with formaldehyde is present in a fluid form. 
     
     
         41 . The method of  claim 18 , wherein said HA crosslinked with divinyl sulfone is present in a gel form. 
     
     
         42 . The method of  claim 1 ,  25  or  29 , wherein said viscosupplement comprises HA crosslinked with formaldehyde and divinyl sulfone. 
     
     
         43 . The method of  claim 42 , wherein said HA crosslinked with formaldehyde and divinyl sulfone is present in a gel form. 
     
     
         44 . A method for treating a hip joint of a human subject suffering from a joint pathology, the method comprising a treatment regimen, the regimen being characterized by the step of administering a single administration dose, within a 24 hour period, of 6 ml of a hyaluronan (HA) based viscosupplement that does not contain additional active components, hylan G-F 20, intra-articularly into the hip joint of said human subject; wherein said treatment regimen does not comprise administering the viscosupplement in weekly intervals. 
     
     
         45 . The method of  claim 44 , wherein the joint pathology is associated with osteoarthritis. 
     
     
         46 . The method of  claim 44 , wherein said single administration dose consists of a single injection of said viscosupplement. 
     
     
         47 . The method of  claim 20 , wherein the single administration dose consists of a single injection of said viscosupplement. 
     
     
         48 . The method of  claim 23 , wherein the single administration dose consists of a single injection of said viscosupplement.

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