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US 2025/0017882 A1Published application
Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
AssigneeFlamel Ireland Limited
InventorsJulien Grassot, Cendrine Grangeon, Jordan Dubow
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Abstract
Oral pharmaceutical compositions of sodium oxybate having improved pharmacokinetic properties when administered less than two hours after eating are provided, and therapeutic uses thereof.
Claims30
A method of treating a human patient in need thereof, the method comprising:
- orally administering a formulation that comprises an immediate-release portion and a modified-release portion to the patient, wherein the formulation comprises an amount of gamma-hydroxybutyrate equivalent to from 3.0 g to 12 g of sodium oxybate,
- wherein the orally administering occurs only once daily at bedtime,
- wherein, the administered formulation releases gamma-hydroxybutyrate into the blood stream of the patient, and
- wherein the Cmax of the formulation is dose proportional.
1 more element
A method of treating a human patient in need thereof, the method comprising:
- orally administering a formulation that comprises an immediate-release portion and a modified-release portion to the patient,
- wherein the formulation comprises an amount of gamma-hydroxybutyrate equivalent to from 3.0 g to 12 g of sodium oxybate,
- wherein the orally administering occurs only once daily at bedtime,
- wherein the administered formulation releases gamma-hydroxybutyrate into the blood stream of the patient, and
- wherein the formulation exhibits predictable increases in plasma levels with increasing doses of the formulation.
2 more elements
Dependencies are inferred from the claim text.