EP-4734972-A1 - METHODS OF ADMINISTERING SOLRIAMFETOL TO LACTATING WOMEN

Abstract

Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

Inventors

• TABUTEAU, Herriot

Assignees

• Axsome Therapeutics, Inc.

Dates

Publication Date

20260506

Application Date

20240628

Claims (20)

1. 1 . A method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a human subject treated with solriamfetol comprising: administering solriamfetol orally at a once-daily dose of about 150 mg to the subject; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, wherein the daily infant dose of solriamfetol is reduced to about 0.1 mg/kg or lower.
2. 2. The method of claim 1 , wherein the adverse events are one or more of agitation, insomnia, or reduced weight gain.
3. 3. The method of claim 2, wherein the subject is being treated with solriamfetol for narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, attention deficit/hyperactivity disorder, cognitive impairment, or binge eating disorder.
4. 4. The method of claim 2, wherein the infant does not experience agitation, insomnia, or reduced weight gain due to solriamfetol exposure.
5. 5. The method of claim 4, wherein the subject is from 1 day to 24 months postpartum.
6. 6. The method of claim 4, wherein the subject is from 10 days to 12 months postpartum.
7. 7. A method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a human subject treated with solriamfetol comprising: administering solriamfetol orally at a once-daily dose of about 75 mg to the subject; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, wherein the daily infant dose of solriamfetol is reduced to about 0.05 mg/kg or lower.
8. 8. The method of claim 7, wherein the adverse events are one or more of agitation, insomnia, or reduced weight gain.
9. 9. The method of claim 8, wherein the subject is being treated with solriamfetol for narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, attention deficit/hyperactivity disorder, cognitive impairment, or binge eating disorder.
10. 10. The method of claim 8, wherein the infant does not experience agitation, insomnia, or reduced weight gain due to solriamfetol exposure.
11. 11 .The method of claim 10, wherein the subject is from 1 day to 24 months postpartum.
12. 12. The method of claim 10, wherein the subject is from 10 days to 12 months postpartum.
13. 13. A method for treating a disorder treatable with solriamfetol in a human subject producing breast milk for feeding an infant, comprising: administering solriamfetol orally at a once-daily dose of about 150 mg to the subject; and reducing exposure of the infant to solriamfetol and/or decreasing the potential for adverse events in the infant fed breast milk from the subject, comprising feeding the infant breast milk obtained from the subject at least about 5 hours after administering the solriamfetol to the subject, wherein the daily infant dose of solriamfetol is reduced to about 0.1 mg/kg or lower.
14. 14. The method of claim 13, wherein the disorder treatable with solriamfetol is narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, cognitive impairment, attention deficit/hyperactivity disorder, or binge eating disorder.
15. 15. The method of claim 13, wherein the infant does not experience agitation, insomnia, or reduced weight gain due to solriamfetol exposure.
16. 16. The method of claim 13, wherein the adverse events are one or more of agitation, insomnia, or reduced weight gain.
17. 17. The method of claim 13, wherein the subject is from 1 day to 24 months postpartum.
18. 18. The method of claim 13, wherein the subject is from 10 days to 12 months postpartum.
19. 19. The method of claim 13, wherein the subject is a woman between the ages of 18 and 45 years.
20. 20. A method for treating a disorder treatable with solriamfetol in a human subject producing breast milk for feeding an infant, comprising: administering solriamfetol orally at a once-daily dose of about 75 mg to the subject; and reducing exposure of the infant to solriamfetol and/or decreasing the potential for adverse events in the infant fed breast milk from the subject, comprising feeding the infant breast milk obtained from the subject at least about 5 hours after administering the solriamfetol to the subject, wherein the daily infant dose of solriamfetol is reduced to about 0.05 mg/kg or lower.

Description

METHODS OF ADMINISTERING SOLRIAMFETOL TO LACTATING WOMEN FIELD OF THE INVENTION [0001] The present invention relates to methods of administering solriamfetol to a lactating subject while reducing the potential for adverse events from solriamfetol in an infant fed breast milk from the subject. BACKGROUND OF THE INVENTION [0002] Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor that has received marketing approval in the US for improving wakefulness in adult subjects with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA). Solriamfetol has been demonstrated to be useful in the treatment of a variety of disorders, including excessive daytime sleepiness, cataplexy, narcolepsy, fatigue, depression, bipolar disorder, fibromyalgia, and others. [0003] Pharmacokinetic studies have demonstrated rapid absorption and high oral bioavailability of solriamfetol with dose-proportional exposure (maximum serum concentration and area under the concentration-time curve [AUG]) in animals tested. [0004] The present invention overcomes shortcomings in the art by providing methods of administering solriamfetol to a lactating subject while reducing the potential for adverse events from solriamfetol in an infant fed breast milk from the subject. SUMMARY OF THE INVENTION [0005] The present invention relates to the development of methods of reducing the potential for adverse events from solriamfetol in an infant fed breast milk from the subject. The invention additionally related to a method of reducing exposure to solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol. [0006] Accordingly, one aspect of the invention relates to a method of reducing exposure to solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby reducing exposure to solriamfetol in the infant. [0007] Another aspect of the invention relates to a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: administering solriamfetol orally at a daily dose of between 37.5 mg and 300 mg to the subject; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing the potential for adverse events from solriamfetol in the infant. In some embodiments, the daily dose of solriamfetol is 150 mg. [0008] An aspect of the invention relates to a method treating a disorder treatable with solriamfetol in a subject producing breast milk for feeding an infant, comprising: administering solriamfetol orally at a daily dose of between 37.5 mg and 300 mg to the subject; and reducing exposure to solriamfetol and/or decreasing the potential for adverse events in the infant fed breast milk from the subject comprising feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject. The disorder treatable with solriamfetol can be, without limitation, narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, attention deficit/hyperactivity disorder, cognitive impairment or binge eating disorder. [0009] In some embodiments, the method provides a daily infant dose of solriamfetol of about 0.3 mg or lower. In some embodiments, the method achieves a relative infant dose of less than about 9% of the subject weight-adjusted dose. In some embodiments, the method achieves a relative infant dose of less than about 5% of the subject weight-adjusted dose. [0010] In some embodiments, the infant does not experience agitation, insomnia, or reduced weight gain due to solriamfetol exposure. [0011] In some embodiments, the subject is from 1 day to 24 months postpartum or from 10 days to 12 months postpartum. [0012] In some embodiments, the subject is being treated with solriamfetol for narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, attention deficit/hyperactivity disorder, cognitive impairment, or binge eating disorder. [0013] In some embodiments, the subject is a woman between the ages of 18 and 45 years. [0014] In some embodiments, the adverse events are one or more of agitation, insomnia, or reduced weight gain. [0015] Methods of treating a disorder amenable to treatment with solriamfetol in a subject who is breastfeeding an infant are provided comprising oraliy administering soiriamfetoi at a daily dose of between about 37.5 mg and 300 mg to the subject. [0016] These and other aspects of the invention are set forth in more detail in the description of the invention below. DETAILED DESCRIPTION [0017] The present invention will now be described in