US 12,383,564 B2
Ganaxolone for use in treating tuberous sclerosis complex and seizure disorders
Joseph Hulihan, Radnor, PA (US); Alex Aimetti, Radnor, PA (US); and Scott Braunstein, Radnor, PA (US)
Assigned to Immedica Pharma US Inc., Radnor, PA (US)
Filed by Immedica Pharma US Inc., Radnor, PA (US)
Filed on Oct. 3, 2024, as Appl. No. 18/905,534.
Application 18/905,534 is a continuation of application No. 18/829,810, filed on Sep. 10, 2024.
Application 18/905,534 is a continuation of application No. 18/432,492, filed on Feb. 5, 2024, granted, now 12,115,169.
Application 18/829,810 is a continuation of application No. PCT/US2022/077419, filed on Sep. 30, 2022.
Claims priority of provisional application 63/252,106, filed on Oct. 4, 2021.
Prior Publication US 2025/0025477 A1, Jan. 23, 2025
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/57 (2006.01); A61K 31/00 (2006.01); A61P 25/08 (2006.01)
CPC A61K 31/57 (2013.01) [A61K 31/658 (2023.05); A61P 25/08 (2018.01)] 22 Claims
 
1. A method for treating seizures associated with Lennox-Gastaut syndrome, comprising orally administering to a subject in need thereof ganaxolone in an amount of:
about 150 mg per day for about one week, followed by about 300 mg per day for about one week, followed by about 600 mg per day for about one week, followed by about 1,200 mg per day for about one week, followed by about up to 1,800 mg per day for the remaining treatment period.