US 11,986,454 B1
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 Jun. 22, 2023, as Appl. No. 18/340,005.
Application 18/340,005 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.
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/27 (2006.01); A61B 5/00 (2006.01); A61B 5/20 (2006.01)
CPC A61K 31/27 (2013.01) [A61B 5/201 (2013.01); A61B 5/4839 (2013.01)] 23 Claims
 
1. A method of treating excessive daytime sleepiness in a subject in need thereof, said method comprising:
selecting a subject for not having end stage renal disease;
determining the estimated glomerular filtration rate (eGFR) of the subject, and
(a) providing to the subject having excessive daytime sleepiness and an 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,
wherein n1 is an integer equal to or greater than 5 and n2 is equal to the sum of n1+1,
wherein the subject is not provided a daily dose exceeding a dose equivalent to 75 mg APC; and
(b) providing to the 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 subject is not provided a daily dose exceeding a dose equivalent to 37.5 mg APC.