Claims for Patent: 11,969,404

Summary for Patent: 11,969,404

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:	US18/295,138
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,969,404
Patent Claims:	1. A method of treating a human subject with [R]-2-amino-3-phenylpropylcarbamate (APC) in need thereof having a history of bipolar disorders, said method comprising: determining if the patient has moderate or severe renal impairment based on the estimated glomerular filtration rate (eGFR) of the subject, and (a) providing to a subject having 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 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 a 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. 2. The method of claim 1, wherein the subject has excessive daytime sleepiness. 3. The method of claim 2, wherein the excessive daytime sleepiness is due to obstructive sleep apnea. 4. The method of claim 2, wherein the excessive daytime sleepiness is due to narcolepsy. 5. The method of claim 2, wherein the excessive daytime sleepiness is due to shift work disorder. 6. The method of claim 1, wherein the subject has attention deficit hyperactivity disorder. 7. The method of claim 1, wherein the subject has binge eating disorder. 8. The method of claim 1, wherein the subject experiences a reduced risk of psychiatric adverse reactions. 9. The method of claim 8, wherein the psychiatric adverse reaction is anxiety. 10. The method of claim 8, wherein the psychiatric adverse reaction is insomnia. 11. 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. 12. 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. 13. 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. 14. 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. 15. 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. 16. The method of claim 1, wherein the eGFR is determined using the Modification in Diet in Renal Disease equation. 17. The method of claim 1, wherein n1 is an integer equal to or greater than 7. 18. The method of claim 2, wherein the excessive daytime sleepiness is due to depression.