US 12,246,026 B2
Ganaxolone for use in treatment of status epilepticus
David Czekai, Radnor, PA (US); Maciej Gasior, Radnor, PA (US); Lorianne Masuoka, Radnor, PA (US); Julia Tsai, Radnor, PA (US); Joseph Hulihan, Radnor, PA (US); and Alex Aimetti, Radnor, PA (US)
Assigned to Marinus Pharmaceuticals, Inc., Radnor, PA (US)
Filed by Marinus Pharmaceuticals, Inc., Radnor, PA (US)
Filed on Aug. 4, 2021, as Appl. No. 17/393,566.
Application 17/393,566 is a continuation of application No. 17/186,569, filed on Feb. 26, 2021, granted, now 11,110,100.
Application 17/186,569 is a continuation of application No. PCT/US2020/044843, filed on Aug. 4, 2020.
Claims priority of provisional application 62/882,648, filed on Aug. 5, 2019.
Prior Publication US 2022/0202831 A1, Jun. 30, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/573 (2006.01); A61K 9/00 (2006.01); A61P 25/08 (2006.01)
CPC A61K 31/573 (2013.01) [A61K 9/0019 (2013.01); A61P 25/08 (2018.01)] 26 Claims
OG exemplary drawing
 
1. A method for treating status epilepticus (SE), comprising administering to a subject in need thereof:
a) an intravenous bolus of ganaxolone in an amount sufficient to suppress SE, and
b) a continuous intravenous infusion of ganaxolone in an amount sufficient for continued SE suppression, wherein the continuous intravenous infusion i) is initiated periprocedurally with the intravenous bolus, ii) is administered for a treatment period of about 24 hours to about 36 hours and the amount of ganaxolone infused is decreased at least twice during the treatment period, and iii) is intended to produce a ganaxolone plasma concentration in the subject of at least about 500 ng/ml to about 1000 ng/ml for at least about 8 hours to about 12 hours.