Claims for Patent: 9,486,426

Summary for Patent: 9,486,426

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:	14/707,914
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,486,426
Patent Claims:	1. A method for the treatment of cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy in a patient who is currently taking gamma-hydroxybutyrate (GHB) or a salt thereof comprising: administering to the patient a dose of divalproex sodium concomitant to a dose of GHB or salt thereof; and reducing the daily dosage amount of GHB or salt thereof administered to the patient between about 5% and about 50% wherein the 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. 2. The method of claim 1 further comprising monitoring patient response and adjusting the GHB dose to maintain the effect of the GHB. 3. The method of claim 1 wherein the daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is 4.5 g. 4. The method of claim 1 wherein the daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is 6 g. 5. The method of claim 1 wherein the daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is 7.5 g. 6. The method of claim 1 wherein the daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is 9 g. 7. The method of claim 1 wherein the daily dosage amount of GHB or salt thereof administered to the patient is reduced between about 15% and about 50%. 8. The method of claim 1 wherein the daily dosage amount of GHB or salt thereof administered to the patient is reduced by between about 20% and about 50%. 9. A method for the treatment of cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy in a patient who is currently taking gamma-hydroxybutyrate (GHB) or a salt thereof comprising: reducing the daily dosage amount of GHB or salt thereof administered to the patient between about 5% and about 50% during concomitant administration of divalproex sodium, compared to the daily dosage amount of between 4.5 g and 9 g of GHB or salt thereof currently used in the absence of concomitant administration of divalproex sodium. 10. The method of claim 9, wherein the daily dosage amount of GHB or salt thereof administered to the patient is reduced by between about 15% and about 50% compared to the manufacturer's recommended daily dosage amount of GHB or salt thereof. 11. The method of claim 9 further comprising monitoring patient response and adjusting the GHB dose to maintain the effect of the GHB. 12. The method of claim 9 wherein the daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is 4.5 g. 13. The method of claim 12 wherein the daily dosage amount of GHB or salt thereof administered to the patient is reduced by between about 15% and about 50%. 14. The method of claim 13 wherein the daily dosage amount of GHB or salt thereof administered to the patient is reduced at least 20%. 15. A method for the treatment of cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy in a patient who is currently taking divalproex sodium comprising: administering to the patient a starting daily dosage amount of gamma-hydroxybutyrate (GHB) or a salt thereof that is between about 15% and about 25% lower than a manufacturer's recommended starting daily dosage amount of between 4.5 g and 9 g in the absence of concomitant administration of divalproex sodium. 16. The method of claim 15 wherein the starting daily dosage amount of GHB or salt thereof administered to the patient is lower than 4.5 g. 17. The method of claim 16 wherein the starting daily dosage amount of GHB or salt thereof administered to the patient is divided into two equal doses. 18. The method of claim 17 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. 19. The method of claim 15 wherein the starting daily dosage amount of GHB or a salt thereof is reduced by between about 20% and about 25%. 20. The method of claim 15 further comprising monitoring patient response and adjusting the GHB dose to treat the patient. 21. The method of claim 15 wherein the manufacturer's recommended starting daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is 4.5 g. 22. A method for the treatment of cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy in a patient who is currently taking divalproex sodium comprising: administering to the patient a starting daily dosage amount of gamma-hydroxybutyrate (GHB) or a salt thereof that is between about 15% and about 30% lower than the starting daily dosage amount of between 4.5 g and 9 g GHB that would otherwise have been recommended to the patient if the patient was not currently taking divalproex sodium. 23. The method of claim 22 wherein the starting daily dosage amount of GHB or salt thereof administered to the patient who is currently taking divalproex sodium is lower than 4.5 g. 24. The method of claim 23 wherein the starting daily dosage amount of GHB or salt thereof administered to the patient who is currently taking divalproex sodium is divided into two equal doses. 25. The method of claim 24 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. 26. The method of claim 22 further comprising monitoring patient response and adjusting the GHB dose to treat the patient. 27. The method of claim 22 wherein the starting daily dosage amount of GHB or a salt thereof is reduced by between about 20% and about 30%. 28. A method for the treatment of cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy in a patient who is currently taking divalproex sodium comprising the steps of: administering to the patient a daily dosage amount of gamma-hydroxybutyrate (GHB) or a salt thereof that is between about 15% and about 30% lower than 4.5 g. 29. The method of claim 28 wherein the daily dosage amount of GHB or salt thereof administered to the patient is divided into two equal doses. 30. The method of claim 29 wherein the first dose of the two equal doses of GHB or salt thereof administered to the patient is lower than 2.25 g. 31. The method of claim 29 wherein the second dose of the two equal doses of GHB or salt thereof administered to the patient is lower than 2.25 g.