Systems and Methods for Treating an Opioid-Induced Adverse Pharmacodynamic Response

Abstract

Disclosed in certain embodiments is a method of treating or preventing an opioid-induced adverse pharmacodynamic response comprising administering to a patient in need thereof an effective amount of buprenorphine.

1 - 103 . (canceled) 
     
     
         104 . A method of treating or preventing an opioid-induced adverse pharmacodynamic response in a patient identified in need thereof, comprising administering to the patient an analgesically effective combination comprising
 (i) an analgesically effective amount of fentanyl or a pharmaceutically acceptable salt thereof, and   (ii) an effective amount of buprenorphine to treat or prevent said adverse pharmacodynamic response in the patient.   
     
     
         105 . The method of  claim 104 , wherein the patient is on a chronic opioid therapy. 
     
     
         106 . The method of  claim 104 , wherein the patient is an opioid naïve patient. 
     
     
         107 . The method of  claim 104 , wherein the opioid-induced adverse pharmacodynamic response results from administration of an opioid having an E max  of greater than about 25%. 
     
     
         108 . The method of  claim 107 , wherein the opioid-induced adverse pharmacodynamic response results from administration of an opioid having an E max  of greater than about 40%. 
     
     
         109 . The method of  claim 104 , wherein the buprenorphine is selected from the group consisting of buprenorphine base, a pharmaceutically acceptable salt thereof, and mixtures thereof. 
     
     
         110 . The method of  claim 104 , wherein the opioid-induced adverse pharmacodynamic response is selected from the group consisting of bowel dysfunction, nausea, vomiting, somnolence, dizziness, respiratory depression, headache, dry mouth, sedation, sweats, asthenia, hypotension, dysphoria, delirium, miosis, pruritis, urticaria, urinary retention, allodynia, physical dependence, tolerance, and a combination thereof. 
     
     
         111 . The method of  claim 110 , wherein the opioid-induced adverse pharmacodynamic response is bowel dysfunction. 
     
     
         112 . The method of  claim 111 , wherein said method comprises concurrently administering to the patient an effective amount of one or more additional therapeutics selected from the group of laxatives, opioid antagonists, and prokinetic agents. 
     
     
         113 . The method of  claim 104 , wherein the fentanyl or pharmaceutically acceptable salt thereof and the buprenorphine are administered through different routes. 
     
     
         114 . The method of  claim 113 , wherein the fentanyl or pharmaceutically acceptable salt thereof is administered through a transdermal, intravenous, or sublingual route, and the buprenorphine is administered through a transdermal or oral route. 
     
     
         115 . The method of  claim 113 , wherein the fentanyl or pharmaceutically acceptable salt thereof is administered through an intravenous or oral route, and the buprenorphine is administered through a transdermal route. 
     
     
         116 . The method of  claim 104 , wherein the fentanyl or pharmaceutically acceptable salt thereof and the buprenorphine are administered through the same route. 
     
     
         117 . The method of  claim 116 , wherein the fentanyl or pharmaceutically acceptable salt thereof and the buprenorphine are in two separate dosage forms. 
     
     
         118 . The method of  claim 116 , wherein the fentanyl or pharmaceutically acceptable salt thereof and the buprenorphine are both formulated for controlled release. 
     
     
         119 . The method of  claim 116 , wherein the fentanyl or pharmaceutically acceptable salt thereof and the buprenorphine are both formulated for immediate release. 
     
     
         120 . The method of  claim 116 , wherein one of the fentanyl or pharmaceutically acceptable salt thereof and the buprenorphine is formulated for controlled release, and the other is formulated for immediate release. 
     
     
         121 . The method of  claim 104 , wherein the buprenorphine is administered transdermally and at a dosing interval of about 3 or 7 days. 
     
     
         122 . The method of  claim 121 , wherein the fentanyl or pharmaceutically acceptable salt thereof is administered at a dosing interval of about 3 to 7 days.