Claims for Patent: 10,213,400

Summary for Patent: 10,213,400

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:	15/869,792
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,213,400
Patent Claims:	1. A method for reducing adverse effects caused by a combination of gamma-hydroxybutyrate (GHB) or a salt thereof and divalproex sodium in a patient comprising: administering a reduced daily dosage amount of GHB or a salt thereof to the patient of between about 5% to about 35%, compared to a daily dosage amount of GHB or salt thereof administered to the patient in the absence of concomitant administration of divalproex sodium; wherein the patient is concomitantly administered divalproex sodium; wherein the patient is a patient suffering from cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy and currently taking GHB or salt thereof; wherein the daily dosage amount of GHB or salt thereof administered to the patient 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 the patient's response and adjusting the dose of GHB or salt thereof. 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 by between about 20% and about 35%. 8. A method for reducing adverse effects caused by combination of gamma-hydroxybutyrate (GHB) or salt thereof and divalproex sodium in a patient comprising: administering a reduced daily dosage amount of GHB or salt thereof to the patient of between about 5% to and about 35%, compared to a manufacturer's recommended starting daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium; wherein the patient is concomitantly administered divalproex sodium; wherein the patient is a patient suffering from cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy and currently taking GHB or salt thereof; wherein the manufacturer's recommended starting 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. 9. The method of claim 8 further comprising monitoring the patient's response and adjusting the dose of GHB or salt thereof. 10. The method of claim 8 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. 11. The method of claim 8 wherein the manufacturer's recommended starting daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium is divided into two equal doses. 12. The method of claim 11 wherein a first or second dose of the two equal doses of GHB or salt thereof administered to the patient is lower than 2.25 g. 13. The method of claim 8 wherein the daily dosage amount of GHB or salt thereof administered to the patient is reduced by between about 20% and about 35%, compared to manufacturer's recommended starting daily dosage amount of GHB or salt thereof in the absence of concomitant administration of divalproex sodium. 14. The method of claim 13 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. 15. A method for reducing adverse effects caused by combination of gamma-hydroxybutyrate (GHB) or salt thereof and divalproex sodium in a patient comprising: administering to the patient a daily dosage amount of GHB or a salt thereof that is between about 5% and about 35% lower than a starting dosage amount of GHB or a salt thereof that would otherwise have been recommended to the patient if the patient was not currently taking divalproex sodium; wherein the patient is concomitantly administered divalproex sodium; wherein the patient is a patient suffering from cataplexy in narcolepsy or excessive daytime sleepiness in narcolepsy and currently taking GHB or salt thereof; wherein the starting daily dosage amount of GHB or salt hereof is between 4.5 g and 9 g. 16. The method of claim 15 further comprising monitoring the patient's response and adjusting the dose of GHB or salt thereof. 17. The method of claim 15 wherein the daily dosage amount of GHB or a salt thereof administered to the patient who is currently taking divalproex sodium is lower than 4.5 g. 18. The method of claim 15 wherein the daily dosage amount of GHB or a salt thereof administered to the patient who is currently taking divalproex sodium is divided into two equal doses. 19. The method of claim 18 wherein a first or second dose of the two equal doses of GHB or salt thereof administered to the patient is lower than 2.25 g. 20. 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 35%.