Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
AssigneeJazz Pharmaceuticals, Inc.
InventorMark Eller
Life of this patent
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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.
Claims34
A method for treating a patient who is suffering from excessive daytime sleepiness, cataplexy, sleep paralysis, apnea, narcolepsy, sleep time disturbances, hypnagogic hallucinations, sleep arousal, insomnia, or nocturnal myoclonus with gamma-hydroxybutyrate (GHB) or a salt thereof, said method comprising:
- orally administering to the patient in need of treatment at least 5% decrease in an effective dosage amount of the GHB or salt thereof when the patient is receiving a concomitant administration of valproate, an acid, salt, or mixture thereof.
A method of safely administering GHB or a salt thereof for excessive daytime sleepiness, cataplexy, sleep paralysis, apnea, narcolepsy, sleep time disturbances, hypnagogic hallucinations, sleep arousal, insomnia, or nocturnal myoclonus in a human patient who is being administered GHB, said method comprising:
- determining if the patient has taken, or will take, a concomitant dose of valproate, an acid, salt or mixture thereof;
- and
- orally administering a reduced amount of the GHB or salt thereof to the patient wherein the reduction is at least 5% compared to a dose without concomitant administration of valproate, an acid, salt or mixture thereof.
A method for treating a patient who is suffering from narcolepsy, said method comprising:
- administering a therapeutically effective amount of a formulation containing a GHB salt to a patient starting at a concentration of between 350 and 750 mg/ml with a pH of between 6 and 10;
- determining if the patient is also being administered valproate, an acid, salt or mixture thereof;
- warning of a potential drug/drug interaction due to the combination of valproate, an acid, salt or mixture thereof and the GHB salt;
- and
- recommending reducing the dose of the GHB salt at least 15%.
A method for treating a patient who is suffering from narcolepsy, said method comprising:
- administering a therapeutically effective amount of a formulation containing a GHB salt to a patient;
- determining if the patient is also being administered valproate, an acid, salt or mixture thereof;
- recommending a 20% decrease in the starting dose of the GHB salt such that a patient starts taking the GHB salt at an adjusted dosage amount between 3.5 grams and 4 grams the GHB salt per night administered orally.
A method for treating a patient who is suffering from narcolepsy, said method comprising:
- orally administering a therapeutically effective amount of a formulation containing a GHB salt;
- determining if the patient is also being administered valproate, an acid, salt or mixture thereof;
- recommending a 20% decrease in the starting dose of the GHB salt such that the amount that the patient is administered is reduced to about 3.6 grams GHB per day.
Dependencies are inferred from the claim text.