Granted Patent
B2
US 12,318,362 · App. 17/479,121 · Granted Jun 3, 2025
Methods of providing solriamfetol therapy to subjects with impaired renal function
Assignee:
AXSOME MALTA LTD.
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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.
Claims (19)
1. A method of reducing toxicity due to [R]-2-amino-3-phenylpropylcarbamate (APC) administration in a subject having moderate or severe renal impairment, said method comprising:
(a) providing to a subject having an estimated glomerular filtration rate (eGFR) of about 30 mL/min/1.73 m 2 to about 59 mL/min/1.73 m 2 :
a first oral daily dose equivalent to 37.5 mg APC from day one to day n 1 of a dose escalation regimen, and
a second oral daily dose equivalent to 75 mg APC starting on day n 2 of the dose escalation regimen,
wherein n 1 is an integer equal to or greater than 6 and n 2 is equal to the sum of n 1 +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 an eGFR of about 15 mL/min/1.73 m 2 to about 29 mL/min/1.73 m 2 :
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 subject has excessive daytime sleepiness.
3. The method of claim 2 , wherein the excessive daytime sleepiness is associated with narcolepsy.
4. The method of claim 2 , wherein the excessive daytime sleepiness is associated with obstructive sleep apnea.
5. 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.
6. 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.
7. 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.
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 upon the subject's awakening.
9. 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.
10. The method of claim 1 , wherein the subject is a human.
11. The method of claim 1 , wherein the eGFR is determined using the Modification of Diet in Renal Disease equation.
Assignments (5)
SECURITY INTEREST
Recorded May 9, 2025
From: AXSOME THERAPEUTICS, INC.; AXSOME MALTA LTD.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 071247/0836 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 28, 2025
From: ZOMORODI, KATAYOUN
To: JAZZ PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 070660/0222 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 28, 2025
From: JAZZ PHARMACEUTICALS IRELAND LIMITED
To: AXSOME MALTA LTD.
Reel/Frame 070660/0644 →
SECURITY INTEREST
Recorded Sep 9, 2024
From: AXSOME MALTA LTD
To: HERCULES CAPITAL, INC.
Reel/Frame 068900/0023 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jun 16, 2022
From: JAZZ PHARMACEUTICALS IRELAND LIMITED
To: AXSOME MALTA LTD.
Reel/Frame 060223/0878 →
Continuity (3)
Continuation
16824560
· Mar 19, 2020
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