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US 2025/0025437 A1Published application
Modified release gamma- hydroxybutyrate formulations having improved pharmacokinetics
AssigneeFlamel Ireland Limited
InventorsClaire Mégret, Hervé Guillard, Jean-François Dubuisson
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Abstract
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Claims14
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 orally administering occurs only once nightly,
- the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 3.0 g, 4.5 g, 6.0 g, 7.5 g, 9.0 g, or 10.5 g of sodium oxybate,
- after the orally administering, the formulation releases gamma-hydroxybutyrate into the blood stream of the patient, and
- wherein the once-nightly formulation achieves a relative bioavailability (RBA) of greater than 80%.
2 more elements
Dependencies are inferred from the claim text.