Granted Patent
B2
US 12,194,016 · App. 18/627,708 · Granted Jan 14, 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 (15)
1. A method of treating excessive daytime sleepiness in a human subject in need thereof, comprising:
selecting a subject and determining the estimated glomerular filtration rate (eGFR) of the subject; and
providing to the subject having excessive daytime sleepiness and an eGFR of about 60 mL/min/1.73 m 2 to about 89 mL/min/1.73 m 2 or about 90 mL/min/1.73 m 2 or greater, a first oral daily dose equivalent to 75 mg [R]-2-amino-3-phenylpropylcarbamate (APC) for 3 days; and
subsequently providing to the subject a second oral daily dose equivalent to 150 mg APC for at least 3 days.
2. The method of claim 1 , further comprising:
providing to the subject a third oral daily dose equivalent to 300 mg APC subsequent to the second oral daily dose.
3. The method of claim 1 , wherein the excessive daytime sleepiness is due to narcolepsy.
4. The method of claim 1 , wherein the excessive daytime sleepiness is due to obstructive sleep apnea.
5. The method of claim 1 , wherein the excessive daytime sleepiness is due to shift work disorder.
6. 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 89.3 mg APC-HCl.
7. The method of claim 1 , wherein the subject is provided said second oral daily dose in the form of about 178.5 mg APC-HCl.
8. The method of claim 1 , wherein said first oral daily dose and said second oral daily dose are each administered upon the subject's awakening.
9. The method of claim 1 , wherein said first oral daily dose and said second 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 excessive daytime sleepiness is due to depression.
11. The method of claim 1 , wherein the eGFR is determined using the Modification of Diet in Renal Disease equation.
Assignments (3)
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: JAZZ PHARMACEUTICALS IRELAND LIMITED
To: AXSOME MALTA LTD.
Reel/Frame 070660/0815 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 28, 2025
From: ZOMORODI, KATAYOUN
To: JAZZ PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 070659/0886 →
Continuity (5)
Continuation
16824560
· Mar 19, 2020
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