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To: Cal Gary who wrote (13009)	10/11/2003 11:02:03 PM
From: Cal Gary	Read Replies (1) \| Respond to of 14101

Transcibed notes of FDA Arthritis Committee meeting where a letter from our very own Dr Shainhouse is entered into FDA records. Monday, July 29, 2002 8:00 a.m. Page 245 2 DR. FIRESTEIN: Thank you. 3 The final presentation will be by Dr. 4 Michael Hufford, Vice President, Scientific 5 Affairs, The Science of Patient Experience. 6 While he is getting set up, I would just 7 let the panel know that there is, in addition, a 8 letter from Dr. Shainhouse that will be entered 9 into the record, but will not be read today. 10 Letter from Z. Shainhouse, M.D., 11 Dimethaid Health Care, Ltd. 12 "As Dimethaid Health Care, Inc. has an 13 interest in topical NSAIDs for symptom relief of 14 rheumatic diseases, we would appreciate the panel 15 taking into consideration the application of any 16 proposed trial models and designs to a topical 17 NSAID. 18 "In trial design for topicals in OA 19 symptom relief, one can use as a model the usual 20 designs for oral NSAIDs. The efficacy variables of 21 pain and physical function, which are used to 22 assess the study joint, are readily studied with 23 topicals. The role of the Patient Global 24 Assessment is less clear. 25 "Questions on Patient Global Assessment 246 1 are often used to inquire about the non-signal 2 joints which are treated simultaneously by oral 3 NSAIDs that provide full, systematic distribution 4 of a therapeutic concentration of drug. 5 "The site-specific nature of topical 6 treatment is unlikely to deliver fully-therapeutic 7 systemic drug levels to provide 'global' benefit to 8 other, non-study joints. Even if one restricts 9 enrollment through trial design, non-study joints 10 may flare during the trial. A Patient Global 11 Assessment for a topical cannot mean the same thing 12 as for an oral. 13 "There are other aspects unique to the 14 study of topicals. Approvability trials, for 15 reasons of practicality and design standards, 16 always study the hip or knee. Topicals are not 17 appropriate for treatment of hips. There is very 18 little literature for oral NSAIDs, let alone 19 topicals, in the treatment of other joints. Do we 20 have sufficient studies on the natural history and 21 spontaneous remission of symptoms in other joints 22 to determine the appropriate duration of study? 23 For that matter, is the now-standard 3-month trial 24 design for OA of the knee or hip based on any such 25 evidence on the natural history of the disease? 247 1 "Clinical experience suggests that where 2 disease is less than bone on bone, symptoms do, 3 indeed, tend to resolve with time - which is 4 perhaps the basis for the usual recommendations to 5 stop oral NSAIDs when symptoms resolve. Is this not 6 further proven by the failure of so many patients 7 to 'flare' during the screening, washout-out stage 8 for drug studies? 9 "The literature describes a significant 10 placebo effect for topicals, thereby complicating 11 study of the onset of pain relief. 12 "In Europe, topical NSAIDs are usually 13 approved and prescribed for the treatment of soft 14 tissue injuries. We are aware of no guidelines for 15 trial design for such studies. Duration would of 16 necessity be shorter because of the self-limited 17 nature of the disorder. 18 "We will appreciate comments from the 19 panel members on the applicability of any 20 guidelines they may propose to the field of topical 21 NSAIDs." 22 "Sincerely, Z. Shainhouse, M.D." 23 [End of letter] fda.gov