Lidocaine patch and methods of use thereof

Abstract

This invention is directed to a transdermal delivery patch comprising local anesthetic agent and optionally a permeation enhancement agent for reducing neuropathic pain.

What is claimed is: 
     
         1 . A patch for transdermal delivery of lidocaine for reducing pain comprising, a patch comprising a composition comprising a therapeutically effective amount of lidocaine, wherein said amount of lidocaine is less than 4 percent by weight, and wherein said pain is selected from neuropathic pain, osteoarthritis pain, back pain, pain associated with fibromyalgia, pain associated with carpal tunnel syndrome, pain associated with muscle strain, pain associated with muscle sprain or degenerative bone pain, or any combination thereof. 
     
     
         2 . The patch of  claim 1 , wherein said composition further comprises a treatment enhancing amount of a permeation enhancement agent. 
     
     
         3 . The patch of  claim 2 , wherein said permeation enhancement agent is menthol. 
     
     
         4 . The patch of  claim 3 , wherein said treatment enhancing amount of menthol is up to 16 percent by weight. 
     
     
         5 . The patch of  claim 4 , wherein said treatment enhancing amount of menthol is about 3 to 5 percent by weight. 
     
     
         6 . The patch of  claim 1 , wherein said therapeutically effective amount of lidocaine is 3.95 percent by weight. 
     
     
         7 . The patch of  claim 1 , wherein said lidocaine is its pharmaceutically acceptable free base. 
     
     
         8 . A method for reducing pain in a subject comprising, applying on a skin surface of said subject, at or near the site of pain, a patch comprising a composition comprising a therapeutically effective amount of lidocaine, wherein said amount of lidocaine is less than 4 percent by weight, and wherein application of said patch provides transdermal delivery of an amount of lidocaine sufficient to reduce said pain in the subject, wherein said pain is selected from neuropathic pain, osteoarthritis pain, back pain, pain associated with fibromyalgia, pain associated with carpal tunnel syndrome, pain associated with muscle strain, pain associated with muscle sprain or degenerative bone pain, or any combination thereof and wherein said patch induces analgesia. 
     
     
         9 . The method of  claim 8 , wherein said applying is for about 8 to 12 hours. 
     
     
         10 . The method of  claim 8 , wherein said neuropathic pain comprises back pain, diabetic neuropathic pain, nerve compression or nerve trauma, or any combination thereof. 
     
     
         11 . The method of  claim 8 , wherein said composition further comprises a treatment enhancing amount of a permeation enhancement agent. 
     
     
         12 . The method of  claim 11 , wherein said permeation enhancement agent is menthol. 
     
     
         13 . The method of  claim 12 , wherein said treatment enhancing amount of menthol is up to 16 percent by weight. 
     
     
         14 . The method of  claim 13 , wherein said treatment enhancing amount of menthol is about 3 to 5 percent by weight. 
     
     
         15 . The method of  claim 8 , wherein said therapeutically effective amount of lidocaine is 3.95 percent by weight. 
     
     
         16 . The method of  claim 8 , wherein said lidocaine is its pharmaceutically acceptable free base. 
     
     
         17 . The method of  claim 8 , wherein said pain is reduced for at least 12 hours. 
     
     
         18 . The method of  claim 17 , wherein said pain is reduced for at least 24 hours. 
     
     
         19 . The method of  claim 19 , wherein said pain is reduced for greater than 24 hours. 
     
     
         20 . The method of  claim 8 , further comprising an additional step for enhanced delivery of said lidocaine. 
     
     
         21 . The method of  claim 20 , wherein said enhanced delivery comprises accelerated delivery by iontophoresis, a battery powered electronic stimulant or magnetophoresis.