Method of administration of gamma hydroxybutyrate with monocarboxylate transporters

Abstract

One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.

1 - 26 . (canceled) 
     
     
         27 . A computer-based method for distributing a drug containing gamma-hydroxybutyrate (GHB) or a salt thereof, comprising:
 identifying an approved pharmacy that has an established management system to dispense information related to risks associated with ingesting valproate concomitantly with a drug containing GHB to a patient prescribed the drug containing GHB;   providing the approved pharmacy with the information; and   authorizing distribution of the drug containing GHB to the approved pharmacy, thereby enabling the approved pharmacy to dispense the drug containing GHB with the information when filling a prescription for the drug containing GHB.   
     
     
         28 . The method of  claim 27 , wherein the information further comprises information related to dose reduction of the drug containing GHB. 
     
     
         29 . The method of  claim 27 , wherein the management system is a computer-based system. 
     
     
         30 . The method of  claim 29 , wherein the management system is a risk evaluation and mitigation strategy (REMS) system. 
     
     
         31 . The method of  claim 29 , further comprises monitoring for concomitant use of valproate. 
     
     
         32 . The method of  claim 27 , further comprising providing an electronic alert to approved pharmacy employees to dispense the information with the drug containing GHB when the prescription is filled. 
     
     
         33 . The method of  claim 27 , further comprising providing an electronic alert warning approved pharmacy employees that the patient is concomitantly using valproate. 
     
     
         34 . The method of  claim 27 , comprising advising the patient of the risks of concomitant ingestion of GHB and valproate. 
     
     
         35 . The method of  claim 27 , wherein the information comprises advising the patient of the potential for enhanced potency of GHB when the patient also takes valproate. 
     
     
         36 . The method of  claim 27 , wherein the information comprises advising the patient of a potential drug/drug interaction due to the combination of valproate and the drug containing GHB. 
     
     
         37 . The method of  claim 27 , wherein the information comprises any one or more of the following: (a) advising the patient that valproate should be avoided or discontinued, (b) advising the patient that concomitant administration of valproate with drugs that are MCT inhibitors can alter the therapeutic effect or adverse reaction profile of GHB, (c) advising the patient that concomitant administration of GHB with valproate can alter the therapeutic effect or adverse reaction profile of GHB, (d) advising the patient that use of GHB in patients being treated with valproate is contraindicated, (e) advising the patient that concomitant administration of GHB and valproate can result in an increase in exposure to GHB, or (f) advising the patient that valproate should be used with caution in patients receiving GHB due to the potential for increased GHB clearance. 
     
     
         38 . The method of  claim 27 , comprising requiring the approved pharmacy to have the established system prior to distributing the drug containing GHB to the approved pharmacy. 
     
     
         39 . The method of  claim 27 , comprising generating periodic reports, at regular frequencies or intervals, relating to the distribution of the drug containing GHB. 
     
     
         40 . The method of  claim 27 , comprising receiving input from the patient that the patient has experienced an adverse reaction resulting from an ingestion of the drug containing GHB. 
     
     
         41 . The method of  claim 27 , comprising accessing a centralized computer database to determine that a particular pharmacy is the approved pharmacy. 
     
     
         42 . The method of  claim 41 , wherein the centralized computer database is distributed among multiple computers.