Method of treatment with milsaperidone

Patent metadata

Field	Value
Publication number	US-12478619-B2
Application number	US-202418965591-A
Country	US
Kind code	B2
Filing date	Dec 2, 2024
Priority date	Jun 2, 2023
Publication date	Nov 25, 2025
Grant date	Nov 25, 2025

Abstract

Described herein is an improved method of treatment with iloperidone or milsaperidone, of a patient in need of such treatment, comprising accounting for an increase in a serum urate level of the patient during treatment with the iloperidone or milsaperidone.

First claim

What is claimed is:

1 . A method of reducing a possibility of an adverse consequence resulting from an increase in a serum urate level in a patient in need of treatment with milsaperidone, and to whom a therapeutically effective amount of milsaperidone is being administered, comprising:
accounting for the increase in the serum urate level of the patient during treatment with the milsaperidone, wherein the accounting comprises monitoring the serum urate level of the patient.

2 . The method of claim 1 , wherein the treatment with milsaperidone results in the increase in the serum urate level of the patient, and
wherein the accounting has the effect of preventing, limiting a frequency of, or limiting a severity of a disease, a condition, or a symptom caused by hyperuricemia or gout.

3 . The method of claim 1 , wherein the monitoring comprises:
obtaining or having obtained a biological sample from the patient; and testing or having tested the biological sample to determine a concentration of urate in the biological sample.

4 . The method of claim 1 , wherein the monitoring comprises performing the monitoring at one or more milestones selected from:
on or about day 28 of treatment, on or about day 21 of treatment, on or about day 14 of treatment, on or about day 7 of treatment, and prior to treatment of the patient with the milsaperidone.

5 . The method of claim 1 , wherein the accounting further comprises instructing the patient to ask a doctor or a pharmacist before commencing treatment with the milsaperidone if the patient is taking a prescription drug for gout.

6 . The method of claim 1 , wherein the accounting further comprises informing the patient of one or more symptoms of gout, or asking whether the patient is experiencing joint pain.

7 . The method of claim 1 , wherein the accounting further comprises instructing the patient to reduce or avoid consumption of alcohol, sugar-sweetened beverages and foods, high fructose corn syrup, or purine-rich foods.

8 . The method of claim 1 , wherein the accounting further comprises instructing the patient to reduce or avoid co-administration of the milsaperidone with any of a diuretic, low-dose aspirin, niacin, an immunosuppressant, or cyclosporine.

9 . The method of claim 1 , wherein the accounting further comprises initiating treatment with, or increasing a dose of a urate-lowering medication in an event in which the serum urate level of the patient exceeds about 6 mg/dl.

10 . The method of claim 1 , wherein the accounting further comprises instructing the patient to discuss the treatment with a rheumatologist or a primary care physician.

11 . The method of claim 1 , wherein the accounting further comprises monitoring the patient, or instructing the patient to self-monitor for a presence of a symptom of gout,
wherein the symptom of gout is selected from pain, swelling, discoloration or redness, tenderness to touch, and warmth at an affected joint.

12 . The method of claim 1 , wherein the accounting further comprises:
assessing or having assessed whether the patient is afflicted with any one or more of: obesity, congestive heart failure, a metabolic syndrome, chronic kidney disease, hypertension (high blood pressure), psoriasis, cancer, or a genetic condition associated with increased urate; and monitoring the patient for development of hypertension, chronic kidney disease, obesity, diabetes, nephrolithiasis, myocardial infarction, or congestive heart failure.

13 . The method of claim 1 , wherein the accounting further comprises instructing the patient to reduce or avoid physical trauma or risk thereof.

14 . The method of claim 1 , wherein the patient in need of treatment with milsaperidone suffers from a disease or disorder selected from schizophrenia, a schizophreniform disorder, bipolar I disorder, acute manic and mixed episodes associated with bipolar I disorder, agitation associated with Alzheimer's Disease, agitation associated with dementia, agitation associated with autism, Parkinson's Disease Psychosis, or another psychotic disease or disorder.

Assignees

• Vanda Pharmaceuticals Inc

Inventors

• Polymeropoulos Mihael H

Classifications

• G01N33/62

  involving urea · CPC title

• A61P25/18

  Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia · CPC title

• G01N2800/52

  Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis · CPC title

• A61P19/06

  Antigout agents, e.g. antihyperuricemic or uricosuric agents · CPC title

• C12Q1/6883

  for diseases caused by alterations of genetic material · CPC title