US 11,779,557 B1
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Jordan Dubow, St. Louis, MO (US); Cendrine Grangeon, Lyons (FR); Hervé Guillard, Villeurbanne (FR); Claire Mégret, Lyons (FR); and Jean-François Dubuisson, Lyons (FR)
Assigned to Flamel Ireland Limited, Dublin (IE)
Filed by Flamel Ireland Limited, Dublin (IE)
Filed on Feb. 7, 2022, as Appl. No. 17/666,201.
Int. Cl. A61K 31/191 (2006.01); A61P 25/20 (2006.01)
CPC A61K 31/191 (2013.01) [A61P 25/20 (2018.01)] 6 Claims
OG exemplary drawing
 
1. A method of treating cataplexy or excessive daytime sleepiness in a human patient with narcolepsy, the method comprising:
determining the patient has an apnea/hypopnea index equal to or lower than 15;
prescribing to the patient a once-nightly formulation that, after oral administration, releases gamma-hydroxybutyrate into the bloodstream of the patient, wherein the formulation includes an immediate-release portion and a modified-release portion, wherein each once-nightly dosage of the formulation releases an amount of gamma-hydroxybutyrate into the bloodstream equivalent to 3 g to 9 g of sodium oxybate, and wherein the prescribing takes place after the determining; and
instructing the patient to take the formulation only once per night while in bed and to lie down immediately after dosing.