US2012258931A1PendingUtilityA1

Regimens for Intra-Articular Viscosupplementation

42
Assignee: BAILLEUL FRANCOISPriority: Dec 30, 2004Filed: May 3, 2012Published: Oct 11, 2012
Est. expiryDec 30, 2024(expired)· nominal 20-yr term from priority
Inventors:François Bailleul
A61P 5/44A61P 35/00A61P 31/12A61P 25/04A61P 29/00A61P 25/00A61P 19/02A61P 23/00A61P 19/08A61P 19/00A61K 9/0024A61K 31/728
42
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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 - 35 . (canceled) 
     
     
         36 . A method for treating a knee 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 knee joint of said subject, wherein said viscosupplement:
 is a hyaluronan (HA)-based viscosupplement that does not contain additional active components;   comprises between 24 mg and 100 mg of HA;   comprises a crosslinked hyaluronan (HA); and   has a residence half-life in said knee joint of between 11 hours and 8.8 days; and   
       wherein said treatment regimen does not comprise administering the viscosupplement in weekly intervals. 
     
     
         37 . The method of  claim 36 , wherein said subject is human. 
     
     
         38 . The method of  claim 36 , wherein said subject is in need of treatment of joint pain. 
     
     
         39 . The method of  claim 36 , wherein said viscosupplement comprises 8±2 mg/ml HA. 
     
     
         40 . The method of  claim 36 , wherein said HA is of animal origin. 
     
     
         41 . The method of  claim 40 , wherein said HA is produced from rooster combs. 
     
     
         42 . The method of  claim 36 , wherein said HA is of bacterial origin. 
     
     
         43 . The method of  claim 36 , wherein said viscosupplement comprises HA crosslinked with formaldehyde. 
     
     
         44 . The method of  claim 43 , wherein the average molecular weight of said HA crosslinked with formaldehyde is 6,000 kDa. 
     
     
         45 . The method of  claim 43 , wherein at least part of said HA crosslinked with formaldehyde is present in a fluid form. 
     
     
         46 . The method of  claim 36 , wherein said viscosupplement comprises hylan A. 
     
     
         47 . The method of  claim 36 , wherein said viscosupplement comprises HA crosslinked with divinyl sulfone. 
     
     
         48 . The method of  claim 47 , wherein said HA crosslinked with divinyl sulfone is present in a gel form. 
     
     
         49 . The method of  claim 36 , wherein said viscosupplement comprises HA crosslinked with formaldehyde and divinyl sulfone. 
     
     
         50 . The method of  claim 49 , wherein said HA crosslinked with formaldehyde and divinyl sulfone is present in a gel form. 
     
     
         51 . The method of  claim 36 , wherein said viscosupplement comprises hylan B. 
     
     
         52 . The method of  claim 36 , wherein said viscosupplement comprises hylan A and hylan B. 
     
     
         53 . The method of  claim 52 , wherein the ratio of hylan A/hylan B is 9/1 by weight of HA. 
     
     
         54 . The method of  claim 36 , wherein said single administration dose consists of a single injection of said viscosupplement. 
     
     
         55 . The method of  claim 36 , wherein said single administration dose consists of a single injection or multiple injections of said viscosupplement. 
     
     
         56 . The method of  claim 36 , wherein 10% of said HA by weight of HA is in a gel form. 
     
     
         57 . The method of  claim 36 , wherein said viscosupplement is hylan G-F 20. 
     
     
         58 . The method of  claim 36 , wherein a therapeutic effect is assessed by:
 a) measuring an improvement in a degree of functional impairment of said knee joint;   b) measuring a reduction in joint pain in said knee joint; or   c) a global status assessment.   
     
     
         59 . A method for treating a knee 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 knee joint of said human subject, wherein said viscosupplement:
 is a hyaluronan (HA)-based viscosupplement that does not contain additional active components;   comprises between 24 mg and 100 mg of HA;   comprises a crosslinked hyaluronan (HA); and   has a residence half-life in said knee joint of between 11 hours and 8.8 days; and   
       wherein said treatment regimen does not comprise administering the viscosupplement in weekly intervals. 
     
     
         60 . The method of  claim 59 , wherein said joint pathology is associated with osteoarthritis. 
     
     
         61 . The method of  claim 59 , wherein said subject is in need of treatment of joint pain. 
     
     
         62 . The method of  claim 59 , wherein said single administration dose consists of a single injection of said viscosupplement. 
     
     
         63 . A method for treating osteoarthritic pain in a knee joint of a human subject, 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 knee joint of said human subject wherein said viscosupplement:
 is a hyaluronan (HA)-based viscosupplement that does not contain additional active components;   comprises between 24 mg and 100 mg of HA;   comprises a crosslinked hyaluronan (HA); and   has a residence half-life in said knee joint of between 11 hours and 8.8 days; and   
       wherein said treatment regimen does not comprise administering the viscosupplement in weekly intervals. 
     
     
         64 . The method of  claim 63 , wherein said subject is in need of treatment of joint pain. 
     
     
         65 . The method of  claim 63 , wherein said single administration dose consists of a single injection of said viscosupplement.

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