Claims for Patent: 10,940,133

Summary for Patent: 10,940,133

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:	US16/824,560
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,940,133
Patent Claims:	1. A method of treating excessive daytime sleepiness associated with obstructive sleep apnea in a renally impaired subject in need thereof according to a dose escalation regimen, said method comprising providing to the subject a first oral daily dose equivalent to 37.5 mg [R]-2-amino-3-phenylpropylcarbamate (APC) from day one to day n1 of the dose escalation regimen; and providing to the subject 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 wherein the renally impaired subject has an estimated glomerular filtration rate (eGFR) of about 30 mL/min/1.73 m2 to about 59 mL/min/1.73 m2. 2. The method of claim 1, wherein the subject is provided the first oral daily dose in the form of about 44.7 ma APC-HCl. 3. The method of claim 1, wherein the subject is provided the second oral daily dose in the form of about 89.3 mg APC-HCl. 4. The method of claim 1, wherein the subject is provided a first oral daily dose in the form of about 44.7 mg APC-HCl and a second oral daily dose in the form of about 89.3 mg APC-HCl. 5. The method of claim 1, wherein the first oral daily dose and second oral daily dose are each administered upon the subject's awakening. 6. The method of claim 1, wherein the first oral daily dose and second oral daily dose are each administered more than nine hours in advance of the subject's bedtime. 7. The method of claim 1, wherein the subject is a human. 8. The method of claim 1, wherein the eGFR is determined using the Modification in Diet in Renal Disease equation. 9. The method of claim 1, wherein n1 is an integer equal to or greater than 7.