Claims for Patent: 12,005,036

Summary for Patent: 12,005,036

Title:	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.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Malta Ltd
Application Number:	US18/491,291
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,005,036
Patent Claims:	1. A method of avoiding exposing an infant of a nursing human mother being treated with solriamfetol to peak concentrations of solriamfetol excreted in breast milk, the method comprising not feeding the infant breast milk obtained within at least about 3.5 hours of the mother receiving an oral once-daily dose of about 150 mg solriamfetol, wherein the median Tmax of solriamfetol excreted in the breast milk is approximately 1.1 hour, wherein a daily infant dose of solriamfetol is reduced to about 0.3 mg or lower. 2. The method of claim 1, wherein the infant is not fed breast milk obtained within at least about 5 hours of the mother receiving an oral once-daily dose of solriamfetol. 3. The method of claim 1, wherein the infant does not experience agitation due to exposure to the solriamfetol. 4. The method of claim 1, wherein the infant does not experience insomnia due to exposure to the solriamfetol. 5. The method of claim 1, wherein the infant does not experience anorexia and/or reduced weight gain due to exposure to the solriamfetol. 6. The method of claim 1, wherein the solriamfetol is excreted in the breast milk with a milk to plasma AUC ratio of approximately 2:1. 7. The method of claim 1, wherein the elimination half-life of the solriamfetol excreted in the breast milk is approximately 5 hours. 8. The method of claim 1, wherein breast milk produced by the nursing mother during the at least about 3.5 hours of the mother receiving an oral once-daily dose of solriamfetol is expressed and discarded. 9. The method of claim 1, wherein the mother is being treated with solriamfetol for excessive daytime sleepiness, narcolepsy, obstructive sleep apnea, shift work disorder, attention deficit hyperactivity disorder, Parkinson's disease, binge eating disorder, or cognitive impairment. 10. The method of claim 9, wherein the excessive daytime sleepiness is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 11. The method of claim 9, wherein the cognitive impairment is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 12. The method of claim 1, wherein the mother is being treated with solriamfetol to improve wakefulness. 13. The method of claim 1, wherein the lactating mother is from about 1 day to about 24 months postpartum. 14. The method of claim 1, wherein the lactating mother is from about 10 days to about 52 weeks postpartum. 15. The method of claim 1, wherein the lactating mother is between the ages of 18 and 45 years. 16. A method of avoiding exposing an infant of a nursing human mother being treated with solriamfetol to peak concentrations of solriamfetol excreted in breast milk, the method comprising not feeding the infant breast milk obtained within at least about 3.5 hours of the mother receiving an oral once-daily dose of about 75 mg solriamfetol, wherein the median Tmax of solriamfetol excreted in the breast milk is approximately 1.1 hour, wherein a daily infant dose of solriamfetol is reduced to about 0.15 mg or lower. 17. The method of claim 16, wherein the infant is not fed breast milk obtained within at least about 5 hours of the mother receiving an oral once-daily dose of solriamfetol. 18. The method of claim 16, wherein the infant does not experience agitation due to exposure to the solriamfetol. 19. The method of claim 16, wherein the infant does not experience insomnia due to exposure to the solriamfetol. 20. The method of claim 16, wherein the infant does not experience anorexia and/or reduced weight gain due to exposure to the solriamfetol. 21. The method of claim 16, wherein the solriamfetol is excreted in the breast milk with a milk to plasma AUC ratio of approximately 2:1. 22. The method of claim 16, wherein the elimination half-life of the solriamfetol excreted in the breast milk is approximately 5 hours. 23. The method of claim 16, wherein breast milk produced by the nursing mother during the at least about 3.5 hours of the mother receiving an oral once-daily dose of solriamfetol is expressed and discarded. 24. The method of claim 16, wherein the mother is being treated with solriamfetol for excessive daytime sleepiness, narcolepsy, obstructive sleep apnea, shift work disorder, attention deficit hyperactivity disorder, Parkinson's disease, binge eating disorder, or cognitive impairment. 25. The method of claim 24, wherein the excessive daytime sleepiness is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 26. The method of claim 24, wherein the cognitive impairment is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 27. The method of claim 1, wherein the mother is being treated with solriamfetol to improve wakefulness. 28. The method of claim 1, wherein the lactating mother is from about 1 day to about 24 months postpartum. 29. The method of claim 1, wherein the lactating mother is from about 10 days to about 52 weeks postpartum. 30. The method of claim 1, wherein the lactating mother is between the ages of 18 and 45 years.