Claims for Patent: 11,160,779

Summary for Patent: 11,160,779

Title:	Methods of providing solriamfetol therapy to subjects with impaired renal function
Abstract:	The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.
Inventor(s):	Katayoun Zomorodi
Assignee:	Axsome Malta Ltd
Application Number:	US17/149,406
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,160,779
Patent 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, 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. 2. The method of claim 1, wherein the excessive daytime sleepiness is associated with narcolepsy. 3. The method of claim 1, wherein the excessive daytime sleepiness is associated with obstructive sleep apnea. 4. The method of claim 1, wherein the subject is provided said first oral daily dose or said oral daily dose in the form of about 44.7 mg APC-HCl. 5. The method of claim 1, wherein the subject is provided said second oral daily dose in the form of about 89.3 mg APC-HCl. 6. The method of claim 1, wherein the subject is provided said first oral daily dose in the form of about 44.7 mg APC-HCl and said second oral daily dose in the form of about 89.3 mg APC-HCl. 7. The method of claim 1, wherein said first oral daily dose, said second oral daily dose, and said oral daily dose are each administered upon the subject's awakening. 8. The method of claim 1, wherein said first oral daily dose, said second oral daily dose, and said oral daily dose are each administered more than nine hours in advance of the subject's bedtime. 9. The method of claim 1, wherein the subject is a human. 10. The method of claim 1, wherein the eGFR is determined using the Modification in Diet in Renal Disease equation. 11. The method of claim 1, wherein n1 is an integer equal to or greater than 7. 12. 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 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, 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; (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; (c) providing to a subject having excessive daytime sleepiness due to narcolepsy and 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 75 mg APC, and after at least 3 days a second oral daily dose equivalent to 150 mg APC, wherein the renally impaired subject is not provided a daily dose exceeding a dose equivalent to 150 mg APC; and (d) providing to a subject having excessive daytime sleepiness due to obstructive sleep apnea and 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 renally impaired subject is not provided a daily dose exceeding a dose equivalent to 150 mg APC.