Claims for Patent: 11,253,494

Summary for Patent: 11,253,494

Title:	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.
Inventor(s):	Eller; Mark (Redwood City, CA)
Assignee:	Jazz Pharmaceuticals Ireland Limited (Dublin, IE)
Application Number:	17/216,540
Patent Claims:	1. A method for treating a patient who is concomitantly administered divalproex sodium, the method comprising: administering to the patient a daily dosage amount of gamma-hydroxybutyrate (GHB) or a salt thereof concomitant to a dose of divalproex sodium, wherein the daily dosage amount of GHB or salt thereof is about 15% to about 35% lower than the recommended daily dosage amount in the absence of concomitant administration of divalproex sodium; wherein the recommended daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is between 4.5 g and 9 g. 2. The method of claim 1, wherein the daily dosage amount of GHB or salt thereof administered to the patient is lower than 4.5 g. 3. The method of claim 2, wherein the daily dosage amount of GHB or salt thereof administered to the patient is lower than 3.6 g. 4. The method of claim 2, wherein the daily dosage amount of GHB or salt thereof administered to the patient is divided into two equal doses. 5. The method of claim 4, wherein the first or second dose of the two equal doses of GHB or salt thereof administered to the patient is lower than 2.25 g. 6. The method of claim 1, wherein the daily dosage amount of GHB or salt thereof administered to the patient is about 15% to about 30% lower than the recommended daily dosage amount in the absence of concomitant administration of divalproex sodium. 7. The method of claim 1, wherein the daily dosage amount of GHB or salt thereof administered to the patient is about 20% lower than the recommended daily dosage amount in the absence of concomitant administration of divalproex sodium. 8. The method of claim 1, wherein the recommended daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is 4.5 g. 9. The method of claim 1, wherein the recommended daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is between 6 g and 9 g. 10. The method of claim 1, wherein the recommended daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is between 7.5 g and 9 g. 11. The method of claim 1, wherein the recommended daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is 9 g. 12. The method of claim 1, wherein the recommended daily dosage amount of GHB or salt thereof is the manufacturer's recommended daily dosage amount of GHB or salt thereof. 13. The method of claim 1, wherein the patient is suffering from excessive daytime sleepiness. 14. A method for treating a patient who is concomitantly administered divalproex sodium, the method comprising: administering to the patient a daily dosage amount of gamma-hydroxybutyrate (GHB) or a salt thereof concomitant to a dose of divalproex sodium, wherein the daily dosage amount of GHB or salt thereof is about 15% to about 35% lower than the recommended daily dosage amount of in the absence of concomitant administration of divalproex sodium; wherein the recommended daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is between 1 g and 6 g. 15. The method of claim 14, wherein the daily dosage amount of GHB or salt thereof administered to the patient is lower than 3 g. 16. The method of claim 14, wherein the daily dosage amount of GHB or salt thereof administered to the patient is divided into two equal doses. 17. The method of claim 14, wherein the daily dosage amount of GHB or salt thereof administered to the patient is about 20% lower than the recommended daily dosage amount in the absence of concomitant administration of divalproex sodium. 18. The method of claim 14, wherein the recommended daily dosage amount of GHB or salt thereof is the manufacturer's recommended daily dosage amount of GHB or salt. 19. The method of claim 14, wherein the patient is suffering from excessive daytime sleepiness. 20. A method for reducing adverse effects caused by a combination of gamma-hydroxybutyrate (GHB) or a salt thereof and divalproex sodium in a patient who is concomitantly administered divalproex sodium, the method comprising: administering a daily dosage amount of GHB or a salt thereof to the patient that is about 15% to about 35% lower as compared to a daily dosage amount of GHB or salt thereof administered in the absence of divalproex sodium; wherein the daily dosage amount of GHB or salt thereof administered in the absence of concomitant administration of divalproex sodium is between 4.5 g and 9 g. 21. The method of claim 20, wherein the daily dosage amount of GHB or salt thereof administered to the patient is about 15% and about 30% lower as compared to a daily dosage amount of GHB or salt thereof administered in the absence of divalproex sodium. 22. The method of claim 20, wherein the daily dosage amount of GHB or salt thereof administered to the patient is about 20% lower as compared to a daily dosage amount of GHB or salt thereof administered in the absence of divalproex sodium. 23. The method of claim 20, wherein the daily dosage amount of GHB or salt thereof administered to the patient is lower than 4.5 g. 24. The method of claim 20, wherein the patient is suffering from excessive daytime sleepiness. 25. A method for treating a patient comprising: administering a reduced daily dosage amount of gamma-hydroxybutyrate (GHB) or a salt thereof to a patient who is concomitantly administered divalproex sodium; wherein the recommended daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is between 4.5 g to 9 g; and wherein the reduced daily dosage amount of GHB or salt thereof compensates for pharmacokinetic (PK) and/or pharmacodynamic (PD) changes caused by the divalproex sodium. 26. The method of claim 25, wherein the PD interactions are measured by Cognitive Drug Research (CDR) system tasks or Karolinska Sleepiness Scale (KSS). 27. The method of claim 25, wherein the PK changes are measured by one or more parameters selected from the group consisting of plasma concentration, C.sub.max, C.sub.n, C.sub.24, T.sub.max, and Area Under the Curve (AUC). 28. The method of claim 25, wherein the daily dosage amount of GHB or salt thereof administered to the patient is reduced by about 15% to about 30%, compared to recommended daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium. 29. The method of claim 25, wherein the daily dosage amount of GHB or salt thereof administered to the patient is reduced by about 20%, compared to recommended daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium. 30. The method of claim 25, wherein the patient is suffering from excessive daytime sleepiness.