Combination of pimavanserin and cytochrome P450 modulators

• US 10,517,860 B2
• Filed: 04/09/2019
• Issued: 12/31/2019
• Est. Priority Date: 03/25/2016
• Status: Active Grant

• Current Assignee: Acadia Pharmaceuticals Inc.
• Original Assignee: Acadia Pharmaceuticals Inc.
• Inventors: Parkinson, Andrew
• Primary Examiner(s): Pihonak, Sarah
• Application Number:
  US16/379,169
• Publication Number:
  US 20190231767A1
• Time in Patent Office: 266 Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/4468 having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/00 Medicinal preparations characterised by special physical form nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Abstract

A method for treating a disease or disorder in a patient who is currently taking a cytochrome P450 inhibitor comprising administering to the patient a dose of pimavanserin or a pharmaceutical acceptable salt thereof, wherein the dose is at least 20% lower than a dose of pimavanserin or a pharmaceutical acceptable salt thereof that would otherwise have been recommended to the patient if the patient were not currently taking the cytochrome P450 inhibitor.

Claims

1. A method of treating psychosis secondary to neurodegenerative disorders in a patient in need thereof, wherein the patient is being treated concurrently with a strong CYP3A4 inhibitor selected from the group consisting of:

ketoconazole, clarithromycin, indinavir, and itraconazole, comprising orally administering to the patient 10 mg of pimavanserin or a pharmaceutically acceptable salt thereof once daily.

2. The method of claim 1, wherein the 10 mg of pimavanserin is a unit dose comprising pimavanserin tartrate.

3. The method of claim 1, wherein the psychosis is Parkinson'"'"'s disease psychosis or Alzheimer'"'"'s disease psychosis.

4. The method of claim 1, wherein the strong CYP3A4 inhibitor is ketoconazole.

5. A method of treating hallucinations and delusions associated with Parkinson'"'"'s disease in a patient in need thereof, wherein the patient is being treated concurrently with ketoconazole, comprising orally administering to the patient 10 mg of pimavanserin once daily.