CPC A61K 31/22 (2013.01) [A61K 9/14 (2013.01); A61K 9/1676 (2013.01); A61K 9/5015 (2013.01); A61K 9/5026 (2013.01); A61K 9/5042 (2013.01); A61K 9/5078 (2013.01); A61K 9/5084 (2013.01); A61K 31/19 (2013.01)] | 15 Claims |
1. A method of treating a disorder treatable with gamma-hydroxybutyrate in 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 daily at bedtime,
the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 4.5 g, 6.0 g, or 7.5 g of sodium oxybate,
after the orally administering, the formulation releases gamma-hydroxybutyrate into the blood stream of the patient, and
the formulation achieves a mean C8h of:
from 4.7 to 9.0 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 4.5 g of sodium oxybate,
from 6.3 to 16.7 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 6.0 g of sodium oxybate, or
from 13.0 to 40.3 microgram/mL when the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 7.5 g of sodium oxybate.
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