US 11,986,455 B2
Methods of providing solriamfetol therapy to subjects with impaired renal function
Katayoun Zomorodi, San Jose, CA (US)
Assigned to AXSOME MALTA LTD., Qormi (MT)
Filed by Axsome Malta Ltd., Qormi (MT)
Filed on Apr. 3, 2023, as Appl. No. 18/295,146.
Application 18/295,146 is a continuation of application No. 17/479,121, filed on Sep. 20, 2021.
Application 17/479,121 is a continuation of application No. 17/149,406, filed on Jan. 14, 2021, granted, now 11,160,779, issued on Nov. 2, 2021.
Application 17/149,406 is a continuation of application No. 16/824,560, filed on Mar. 19, 2020, granted, now 10,940,133, issued on Mar. 9, 2021.
Prior Publication US 2023/0233509 A1, Jul. 27, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/325 (2006.01); A61K 9/00 (2006.01); A61K 31/27 (2006.01); A61P 25/26 (2006.01)
CPC A61K 31/325 (2013.01) [A61K 9/0053 (2013.01); A61K 31/27 (2013.01); A61P 25/26 (2018.01)] 24 Claims
 
1. A method of treating excessive daytime sleepiness in a subject in need thereof having moderate or severe renal impairment, said method comprising:
(a) providing to a subject having excessive daytime sleepiness and an estimated glomerular filtration rate (eGFR) of about 30 mL/min/1.73 m2 to about 59 mL/min/1.73 m2:
a first oral daily dose equivalent to 37.5 mg [R]-2-amino-3-phenylpropylcarbamate (APC) from day one to day n1 of a dose escalation regimen, and
a second oral daily dose equivalent to 75 mg APC starting on day n2 of the dose escalation regimen based on efficacy and tolerability,
wherein n1 is an integer equal to or greater than 5 and n2 is equal to the sum of n1+1,
wherein the renally impaired subject is not provided a daily dose exceeding a dose equivalent to 75 mg APC; and
(b) providing to a subject having excessive daytime sleepiness and an eGFR of about 15 mL/min/1.73 m2 to about 29 mL/min/1.73 m2:
an oral daily dose equivalent to 37.5 mg APC,
wherein the renally impaired subject is not provided a daily dose exceeding a dose equivalent to 37.5 mg APC.