Granted Patent
B2
US 12,648,934 · App. 19/390,174 · Granted Jun 9, 2026
Combination therapy for a dopamine agonist
Assignee:
ALTO NEUROSCIENCE, INC.
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Abstract
The application describes a method of reducing emesis caused by a dopamine agonist in a patient with depression who is treated with a dopamine agonist, comprising administering ondansetron in combination with the dopamine agonist.
Claims (30)
1 . A method for treating a patient suffering from major depressive disorder (MDD), comprising administering to the patient a daily dose of 6 mg to 64 mg of ondansetron, or a pharmaceutically acceptable salt or solvate thereof, and a daily dose of 0.125 mg to 20 mg of pramipexole, or a pharmaceutically acceptable salt or solvate thereof.
2 . The method of claim 1 , comprising administering to the patient a daily dose of about 0.125 mg to about 6 mg of pramipexole, or a pharmaceutically acceptable salt or solvate thereof.
3 . The method of claim 1 , comprising administering to the patient a daily dose of about 0.375 mg to about 6 mg of pramipexole, or a pharmaceutically acceptable salt or solvate thereof.
4 . The method of claim 1 , comprising administering to the patient a daily dose of about 1 mg to about 6 mg of pramipexole, or a pharmaceutically acceptable salt or solvate thereof.
5 . The method of claim 1 , comprising administering pramipexole dihydrochloride monohydrate.
6 . The method of claim 1 , comprising administering to the patient a daily dose of about 0.125 mg to about 6 mg of pramipexole dihydrochloride monohydrate.
7 . The method of claim 1 , comprising administering to the patient a daily dose of about 0.375 mg to about 6 mg of pramipexole dihydrochloride monohydrate.
8 . The method of claim 1 , comprising administering to the patient a daily dose of about 1 mg to about 6 mg pramipexole dihydrochloride monohydrate.
9 . The method of claim 1 , comprising administering to the patient a daily dose of about 1 mg pramipexole dihydrochloride monohydrate.
10 . The method of claim 1 , comprising administering to the patient a daily dose of about 1.5 mg pramipexole dihydrochloride monohydrate.
11 . The method of claim 1 , comprising administering to the patient a daily dose of about 2.0 mg pramipexole dihydrochloride monohydrate.
12 . The method of claim 1 , comprising administering to the patient a daily dose of about 2.5 mg pramipexole dihydrochloride monohydrate.
13 . The method of claim 1 , comprising administering to the patient a daily dose of about 3.0 mg pramipexole dihydrochloride monohydrate.
14 . The method of claim 1 , comprising administering to the patient a daily dose of about 4.0 mg pramipexole dihydrochloride monohydrate.
15 . The method of claim 1 , comprising administering to the patient a daily dose of about 4.5 mg pramipexole dihydrochloride monohydrate.
16 . The method of claim 1 , comprising administering ondansetron hydrochloride dihydrate.
17 . The method of claim 1 , comprising administering to the patient about 6 mg to about 32 mg ondansetron or an equivalent dose of ondansetron hydrochloride dihydrate.
18 . The method of claim 1 , wherein the method comprises administering to the patient about 8 mg to about 16 mg of ondansetron or an equivalent dose of ondansetron hydrochloride dihydrate.
19 . The method of claim 1 , wherein ondansetron, or a pharmaceutically acceptable salt or solvate thereof, and pramipexole, or a pharmaceutically acceptable salt or solvate thereof, are formulated in separate pharmaceutical compositions.
20 . The method of claim 19 , wherein the separate pharmaceutical compositions are administered to the patient concurrently.
21 . The method of claim 19 , wherein the separate pharmaceutical compositions are administered to the patient sequentially.
22 . The method of claim 1 , wherein ondansetron, or a pharmaceutically acceptable salt or solvate thereof, and pramipexole, or a pharmaceutically acceptable salt or solvate thereof, are formulated in the same pharmaceutical composition.
23 . The method of claim 1 , comprising administering to the patient a daily dose of 6 mg to 32 mg of ondansetron, or a pharmaceutically acceptable salt or solvate thereof, and a daily dose of 0.125 mg to 6 mg of pramipexole, or a pharmaceutically acceptable salt or solvate thereof.
24 . The method of claim 23 , comprising administering to the patient a daily dose of about 0.375 mg to about 6 mg of pramipexole, or a pharmaceutically acceptable salt thereof.
25 . The method of claim 23 , wherein the pramipexole is pramipexole dihydrochloride monohydrate.
26 . The method of claim 23 , wherein the ondansetron is ondansetron hydrochloride dihydrate.
27 . The method of claim 1 , comprising administering ondansetron, or a pharmaceutically acceptable salt or solvate thereof, and pramipexole, or a pharmaceutically acceptable salt or solvate thereof, two times per day.
28 . The method of claim 1 , comprising administering ondansetron, or a pharmaceutically acceptable salt or solvate thereof, and pramipexole, or a pharmaceutically acceptable salt or solvate thereof, three times per day.
29 . The method of claim 23 , comprising administering ondansetron, or a pharmaceutically acceptable salt or solvate thereof, and pramipexole, or a pharmaceutically acceptable salt or solvate thereof, two times per day.
30 . The method of claim 23 , comprising administering ondansetron, or a pharmaceutically acceptable salt or solvate thereof, and pramipexole, or a pharmaceutically acceptable salt or solvate thereof, three times per day.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 20, 2026
From: CLARENCE-SMITH, KATHLEEN E.; CHASE, THOMAS N.
To: ALTO NEUROSCIENCE, INC.
Reel/Frame 073851/0599 →
Continuity (4)
Continuation
19244143
· Jun 20, 2025
Continuation
16607252
Provisional Application
62489016
· Apr 24, 2017
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