US2004019111A1PendingUtilityA1

Methods and compositions for the treatment of neuropathic pain, tinnitus, and other disorders using R(-)-ketoprofen

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Assignee: SEPRACOR INCPriority: Mar 2, 1999Filed: Jul 17, 2003Published: Jan 29, 2004
Est. expiryMar 2, 2019(expired)· nominal 20-yr term from priority
Inventors:Thomas JerussiPaul Rubin
A61P 9/10A61P 25/02A61P 27/16A61P 25/04A61P 31/00A61P 29/00A61P 35/00C07B 2200/07A61P 19/00A61K 31/415A61K 31/46C07C 49/84A61K 31/465A61K 31/435C07D 265/32A61K 31/00A61K 31/165A61K 31/137A61K 31/43A61K 31/192
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Claims

Abstract

Methods of treating neuropathic pain, tinnitus, and related disorders are disclosed. These methods comprise the administration of optically pure R(−)-ketoprofen. Also disclosed are pharmaceutical compositions useful in the treatment of neuropathic pain and tinnitus which comprise optically pure R(−)-ketoprofen.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A method of treating neuropathic pain in a mammal which comprises administering to a mammal in need of such treatment a therapeutically effective amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof.  
     
     
         2 . The method of  claim 1  wherein the therapeutically effective amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 1 mg and about 2000 mg.  
     
     
         3 . The method of  claim 2  wherein the therapeutically effective amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 5 mg and about 1500 mg.  
     
     
         4 . The method of  claim 3  wherein the therapeutically effective amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 10 mg and about 1000 mg.  
     
     
         5 . The method of  claim 1  wherein the substantially optically pure R(−)-ketoprofen comprises less than about 10% by weight S(+)-ketoprofen.  
     
     
         6 . The method of  claim 5  wherein the substantially optically pure R(−)-ketoprofen comprises less that about 5% by weight S(+)-ketoprofen.  
     
     
         7 . The method of  claim 6  wherein the substantially optically pure R(−)-ketoprofen comprises less than about 1% by weight S(+)-ketoprofen.  
     
     
         8 . The method of  claim 1  wherein the neuropathic pain is a central neuropathy.  
     
     
         9 . The method of  claim 8  wherein the central neuropathy arises from damage or disease of the spinal cord, brainstem, thalamus, or cerebellum.  
     
     
         10 . The method of  claim 1  wherein the neuropathic pain is a peripheral neuropathy.  
     
     
         11 . The method of  claim 10  wherein the peripheral neuropathy is a thoracic outlet obstruction syndrome, a compression and entrapment neuropathy, or Guillain-Barré syndrome.  
     
     
         12 . The method of  claim 11  wherein the compression and entrapment neuropathy is selected from the group consisting of ulnar nerve palsey, carpal tunnel syndrome, peroneal nerve palsey, and radial nerve palsey.  
     
     
         13 . The method of  claim 1  wherein the mammal is human.  
     
     
         14 . A pharmaceutical composition for the treatment of a mammal suffering from neuropathic pain which comprises an amount of substantially optically pure R(−)-ketoprofen or a pharmaceutically acceptable salt, solvate, or clathrate thereof, said amount being sufficient to alleviate at least one symptom of neuropathic pain.  
     
     
         15 . The pharmaceutical composition of  claim 14  further comprising a pharmaceutically acceptable carrier.  
     
     
         16 . The pharmaceutical composition of  claim 15  wherein the pharmaceutically acceptable carrier is solid.  
     
     
         17 . The pharmaceutical composition of  claim 14  wherein the amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 1 mg and about 2000 mg.  
     
     
         18 . The pharmaceutical composition of  claim 17  wherein the amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 5 mg and about 1500 mg.  
     
     
         19 . The pharmaceutical composition of  claim 18  wherein the amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 10 mg and about 1000 mg.  
     
     
         20 . The pharmaceutical composition of  claim 14  wherein the substantially optically pure R(−)-ketoprofen comprises less than about 10% by weight S(+)-ketoprofen.  
     
     
         21 . The pharmaceutical composition of  claim 20  wherein the substantially optically pure R(−)-ketoprofen comprises less that about 5% by weight S(−)-ketoprofen.  
     
     
         22 . The pharmaceutical composition of  claim 21  wherein the substantially optically pure R(−)-ketoprofen comprises less than about 1% by weight S(+)-ketoprofen.  
     
     
         23 . A single unit dosage form for the treatment of a mammal suffering from neuropathic pain which comprises substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, in an amount of between about 1 mg and about 2000 mg.  
     
     
         24 . The dosage form of  claim 23  wherein the amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 5 mg and about 1500 mg.  
     
     
         25 . The dosage form of  claim 24  wherein the amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 10 mg and about 1000 mg.  
     
     
         26 . The dosage form of  claim 23  which is formulated for oral administration.  
     
     
         27 . The dosage form of  claim 26  which is solid.  
     
     
         28 . A method of treating tinnitus or ringing in the ear in a patient which comprises administering to a patient in need of such treatment a therapeutically effective amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof.  
     
     
         29 . The method of  claim 28  wherein the tinnitus or ringing in the ear is associated with a disease or condition selected from the group consisting of: obstruction of the external auditory canal; infectious processes including external otitis, myrignitis, otitis media, labyrinthitis, petrositis, syphilis and meningitis; eustachian tube obstruction; otosclerosis; middle ear neoplasms such as the glomus tympanicum and glomus jugulare tumors; Meniere's disease; arachnoiditis; cerebellopontine angle tumors; cardiovascular diseases including hypertension, arteriosclerosis and aneurysms; anemia; hypothyroidism; hereditary sensorineural or noise-induced hearing loss; acoustic trauma; ototoxicity caused by acute intoxication or long-term administration or exposure to drugs or toxins including salicylates, quinine and its synthetic analogues, aminoglycoside antibiotics, diuretics, carbon monoxide, and heavy metals; and psychological disorders.  
     
     
         30 . A method of preventing tinnitus or ringing in the ear in a patient at risk of tinnitus which comprises administering to said patient a therapeutically effective amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof.  
     
     
         31 . The method of  claim 28  or  30  wherein the therapeutically effective amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 1 mg and about 2000 mg.  
     
     
         32 . The method of  claim 31  wherein the therapeutically effective amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 5 mg and about 1500 mg.  
     
     
         33 . The method of  claim 32  wherein the therapeutically effective amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 10 mg and about 1000 mg.  
     
     
         34 . The method of  claim 28  or  30  wherein the substantially optically pure R(−)-ketoprofen comprises less than about 10% by weight S(+)-ketoprofen.  
     
     
         35 . The method of  claim 34  wherein the substantially optically pure R(−)-ketoprofen comprises less that about 5% by weight S(+)-ketoprofen.  
     
     
         36 . The method of  claim 35  wherein the substantially optically pure R(−)-ketoprofen comprises less than about 1% by weight S(+)-ketoprofen.  
     
     
         37 . A pharmaceutical composition for the treatment of a patient suffering from tinnitus which comprises an amount of substantially optically pure R(−)-ketoprofen or a pharmaceutically acceptable salt, solvate, or clathrate thereof, said amount being sufficient to alleviate at least one symptom of tinnitus.  
     
     
         38 . The pharmaceutical composition of  claim 37  wherein the amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 1 mg and about 2000 mg.  
     
     
         39 . The pharmaceutical composition of  claim 38  wherein the amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 5 mg and about 1500 mg.  
     
     
         40 . The pharmaceutical composition of  claim 39  wherein the amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 10 mg and about 1000 mg.  
     
     
         41 . A single unit dosage form for the treatment of a patient suffering from tinnitus which comprises substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, in an amount of between about 1 mg and about 2000 mg.  
     
     
         42 . The dosage form of  claim 41  wherein the amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 5 mg and about 1500 mg.  
     
     
         43 . The dosage form of  claim 42  wherein the amount of substantially optically pure R(−)-ketoprofen, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, is between about 10 mg and about 1000 mg.  
     
     
         44 . A composition comprising R(−)-ketoprofen and a pharmaceutically acceptable carrier.

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