Patent ID: 11857528
Assignee: AXSOME MALTA LTD.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 0:
1. A method of treating excessive daytime sleepiness in a subject in need thereof having mild, moderate, or severe renal impairment, said method comprising:
(a) providing to the subject having 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, wherein the APC does not produce an AUC∞ greater than 2.3 times the AUC∞ for a subject without renal impairment;
(b) providing to the subject having 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, and, wherein the APC does not produce an AUC∞ greater than 4.4 times the AUC∞ for a subject without renal impairment; or
(c) providing to the subject having an eGFR of about 60 mL/min/1.73 m2 to about 89 mL/min/1.73 m2:
a first oral daily dose equivalent to 37.5 mg APC,
after at least 3 days a second oral daily dose equivalent to 75 mg APC, and
after at least 3 days a third oral daily dose equivalent to 150 mg APC,, wherein the subject is not provided a daily dose exceeding a dose equivalent to 150 mg APC, and, wherein the APC does not produce an AUC∞ greater than 1.5 times the AUC∞ for a subject without renal impairment.