Treatment of post-operative joint pain with polysulfated polysaccharides

Abstract

The present invention relates to medical use of polysulfated polysaccharides and compositions thereof in the treatment of post-operative joint pain in a mammal. In particular, the invention relates to the use of polysulfated polysaccharides and compositions thereof in the treatment of aseptic persistent pain after joint arthroplasty in a mammal.

1 . A method for the treatment of aseptic post-operative intra-articular joint pain resulting from a joint arthroplasty performed on a mammal, the method comprising the steps of:
 (i) identifying the mammal as suffering from aseptic post-operative intra-articular joint pain which is the direct result of a joint arthroplasty, wherein the mammal is post-operatively not suffering from osteolysis, osteoarthritis or bone marrow edema in said joint; and   (ii) administering an amount of pentosan polysulfate or an acceptable salt thereof, to the mammal, effective to alleviate said aseptic post-operative intra-articular joint pain resulting from the joint arthroplasty.   
     
     
         2 . (canceled) 
     
     
         3 . (canceled) 
     
     
         4 . The method according to  claim 1 , wherein the post-operative joint pain is in at least one articulating joint selected from the group consisting of: an ankle, an elbow, a finger, a hip, a knee, a shoulder, and a wrist. 
     
     
         5 . The method according to  claim 4 , wherein the at least one articulating joint is a knee. 
     
     
         6 . The method according to  claim 1 , wherein the joint arthroplasty is a partial joint arthroplasty selected from the group consisting of: a partial ankle arthroplasty, a partial elbow arthroplasty, a partial finger arthroplasty, a partial hip arthroplasty, a partial knee arthroplasty, a partial shoulder arthroplasty, and a partial wrist arthroplasty. 
     
     
         7 . The method according to  claim 1 , wherein the joint arthroplasty is a total joint arthroplasty selected from the group consisting of: a total ankle arthroplasty, a total elbow arthroplasty, a total finger arthroplasty, a total hip arthroplasty, a total knee arthroplasty, a total shoulder arthroplasty, a total wrist arthroplasty. 
     
     
         8 . (canceled) 
     
     
         9 . The method according to  claim 1 , wherein the post-operative joint pain is selected from the group consisting of: acute pain; chronic pain; persistent pain. 
     
     
         10 . The method according to  claim 9 , wherein the persistent pain is intra-articular persistent pain. 
     
     
         11 . The method according to  claim 1 , wherein the mammal is suffering from an additional arthritic condition further to the post-operative joint pain, in a second joint different from the joint affected by the post-operative pain, wherein the additional arthritic condition is selected from the group consisting of: rheumatic arthritis, osteoarthritis or degenerative osteoarthritis. 
     
     
         12 . (canceled) 
     
     
         13 . (canceled) 
     
     
         14 . The method according to  claim 11 , wherein the second joint is one knee joint and the joint affected by the post-operative pain is another knee joint. 
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . The method according to  claim 1 , wherein the pentosan polysulfate (PPS) or an acceptable salt thereof is selected from the group consisting of: the sodium salt of pentosan polysulfate (NaPPS), the magnesium salt of pentosan polysulfate (MgPPS), the calcium salt of pentosan polysulfate (CaPPS), and the zinc salt of pentosan polysulfate (ZnPPS). 
     
     
         18 . (canceled) 
     
     
         19 . The method according to  claim 1 , wherein treatment is by administering the pentosan sulfate or the acceptable salt thereof to the mammal in an effective amount of about 0.5 to about 2 mg/kg; about 0.5 to about 1 mg/kg; about 1.0 to about 1.5 mg/kg or about 1.5 to about 2.0 mg/kg of the mammal per dose or wherein the effective amount is a fixed dose in the range of about 25 mg to about 4000 mg. 
     
     
         20 . (canceled) 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . The method according to  claim 1 , wherein the treatment is: by administering a subcutaneous (SC) injection, an intramuscular (IM) injection, an intravenous (IV) injection, an intra-articular (IA) injection or a peri-articular injection; by topical administration; via suppositories or by oral administration. 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . The method according to  claim 23 , wherein administration to a human patient is by dosing in a treatment regimen once daily, twice weekly or thrice weekly. 
     
     
         27 . (canceled) 
     
     
         28 . (canceled) 
     
     
         29 . (canceled) 
     
     
         30 . (canceled) 
     
     
         31 . (canceled) 
     
     
         32 . The method according to  claim 1 , wherein pain in a human patient is reduced as determined by using the numerical rating scale (NRS). 
     
     
         33 . The method according to  claim 1 , wherein the function of the knee joint with post-operative pain and/or function of the knee joint with the additional arthritic condition in a human patient is improved as determined by using the Lysholm Knee Score. 
     
     
         34 . (canceled) 
     
     
         35 . (canceled) 
     
     
         36 . (canceled) 
     
     
         37 . A method for the treatment of aseptic post-operative intra-articular joint pain resulting from a joint arthroplasty performed on a mammal, the method comprising the steps of:
 (i) performing a joint arthroplasty on a joint of a mammal in a manner so as to alleviate pain present within the joint;   (ii) identifying the mammal as suffering from aseptic post-operative intra-articular joint pain which is the direct result of the joint arthroplasty, wherein the mammal is post-operatively not suffering from osteolysis, osteoarthritis or bone marrow edema in said joint; and   (iii) treating the aseptic post-operative intra-articular joint pain arising as a direct result of the joint arthroplasty, by injecting an amount of sodium pentosan polysulfate, effective to alleviate said aseptic post-operative intra-articular joint pain resulting from the joint arthroplasty, into said joint.   
     
     
         38 . A method for the treatment of aseptic post-operative intra-articular joint pain resulting from a joint arthroplasty performed on a mammal, the method comprising the steps of:
 (i) determining that pain present in a joint of the mammal is susceptible to pain relief, by performing a joint arthroplasty on said joint; and   (ii) identifying the mammal as suffering from aseptic post-operative intra-articular joint pain which is the direct result of the joint arthroplasty, wherein the mammal is post-operatively not suffering from osteolysis, osteoarthritis or bone marrow edema in said joint; and   (iii) treating the aseptic post-operative intra-articular joint pain arising as a direct result of the joint arthroplasty, by injecting an amount of sodium pentosan polysulfate, effective to alleviate said aseptic post-operative intra-articular joint pain resulting from the joint arthroplasty, into said joint.   
     
     
         39 . A method for the treatment of aseptic post-operative intra-articular joint pain resulting from a joint arthroplasty performed on a human subject, the method comprising the steps of:
 (i) selecting a human subject who has had a joint arthroplasty;   (ii) diagnosing the subject as suffering from aseptic post-operative intra-articular joint pain which is a result of said joint arthroplasty, wherein the subject is post-operatively not suffering from osteolysis, osteoarthritis or bone marrow edema in said joint; and   (iii) administering, based on said diagnosis of step (ii), an amount of sodium pentosan polysulfate to the subject effective to alleviate said aseptic post-operative intra-articular joint pain resulting from said joint arthroplasty.   
     
     
         40 . A method for the treatment of aseptic post-operative intra-articular joint pain resulting from a joint arthroplasty performed on a human subject, the method comprising the steps of:
 (i) selecting a human subject who has had a joint arthroplasty and who has been diagnosed as suffering from aseptic post-operative intra-articular joint pain which is the direct result of said joint arthroplasty, wherein the subject is post-operatively not suffering from osteolysis, osteoarthritis or bone marrow edema in said joint; and   (ii) administering, based on said diagnosis of step (i), an amount of sodium pentosan polysulfate to the subject effective to alleviate said aseptic post-operative intra-articular joint pain resulting from said joint arthroplasty.