METHODS OF PROVIDING SOLRIAMFETOL THERAPY TO SUBJECTS WITH IMPAIRED RENAL FUNCTION
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.
1 . A method of reducing toxicity due to [R]-2-amino-3-phenylpropylcarbamate (APC) in a subject ingesting more than a therapeutically effective dose of APC, said method comprising administering hemodialysis to the subject, wherein approximately 21% of the APC is removed as unchanged drug after the hemodialysis session.
2 . The method of claim 1 , wherein the APC is the hydrochloride salt.
3 . The method of claim 1 , wherein the hemodialysis is a 4 hour session.
4 . The method of claim 3 , wherein the hemodialysis clearance of APC is about 12 hours.
5 . The method of claim 3 , wherein the hemodialysis clearance of APC is about 15 hours.
6 . The method of claim 1 , wherein the subject is being treated for excessive daytime sleepiness.
7 . The method of claim 6 , wherein the excessive daytime sleepiness is due to obstructive sleep apnea.
8 . The method of claim 6 , wherein the excessive daytime sleepiness is due to narcolepsy.
9 . The method of claim 6 , wherein the excessive daytime sleepiness is due to shift work disorder.
10 . The method of claim 1 , wherein the subject is being treated for attention deficit hyperactivity disorder.
11 . The method of claim 1 , wherein the subject is being treated for binge eating disorder.
12 . The method of claim 1 , wherein the therapeutically effective dose is 37.5 mg once daily.
13 . The method of claim 1 , wherein the therapeutically effective dose is 75 mg once daily.
14 . The method of claim 1 , wherein the therapeutically effective dose is 150 mg once daily.
15 . The method of claim 1 , wherein the therapeutically effective dose is 300 mg once daily.
16 . The method of claim 1 , wherein the subject has renal impairment.
17 . The method of claim 1 , wherein the subject is treated concurrently with a monoamine oxidase inhibitor (MAOI) or was treated with an MAOI within the preceding 14 days.