Methods for the treatment of parkinson's disease psychosis using pimavanserin

• US 9,446,037 B2
• Filed: 11/26/2013
• Issued: 09/20/2016
• Est. Priority Date: 11/27/2012
• Status: Active Grant

• Current Assignee: Acadia Pharmaceuticals Inc.
• Original Assignee: Acadia Pharmaceuticals Inc.
• Inventors: Mills, Roger, Williams, Hilde
• Primary Examiner(s): HENLEY III, RAYMOND J
• Application Number:
  US14/647,438
• Publication Number:
  US 20150313888A1
• Time in Patent Office: 1,029 Days
• Field of Search: 514/329
• US Class Current: 1/1
• 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 31/12 Ketones
• CPC Class Codes: A61K 31/13 Amines A61K31/04 takes precedence
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/4045 Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
• CPC Class Codes: A61K 31/428 condensed with carbocyclic rings
• CPC Class Codes: A61K 31/4453 only substituted in position 1, e.g. propipocaine, diperodon
• CPC Class Codes: A61K 31/4468 having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
• CPC Class Codes: A61K 31/46 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
• CPC Class Codes: A61K 31/473 ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• 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
• CPC Class Codes: G09B 19/00 Teaching not covered by other main groups of this subclass teaching or practice apparatus for gun-aiming or gun-laying F41G3/26
• CPC Class Codes: G09B 3/06 of the multiple-choice answer type, i.e. where a given question is provided with a series of answers and a choice has to be made

Abstract

Methods for the treatment of Parkinson'"'"'s disease psychosis which comprise the administration of pimavanserin.

Claims

1. A method for excluding from a clinical study patients with likelihood for placebo response, the method comprising screening a group of psychosis patients by administering social interaction therapy designed for psychosis, wherein patients who respond sufficiently to the social interaction therapy are excluded from a subsequent clinical study.

2. The method according to claim 1, wherein the social interaction therapy is administered one day to two weeks.

3. The method according to claim 1, wherein the social interaction therapy is a brief psycho-social therapy.

4. The method according to claim 1, wherein the patients are Parkinson'"'"'s disease psychosis patients.

5. The method according to claim 1, wherein the social interaction therapy is a non-pharmaceutical therapy.

6. The method according to claim 1, wherein the method is integrated in a clinical trial for psychosis patients.

7. The method according to claim 6, wherein the psychosis patients are Parkinson'"'"'s disease psychosis patients.

8. A method for improvement of daytime wakefulness in a Parkinson'"'"'s disease patient, comprising the oral administration of pimavanserin, or a pharmaceutically acceptable salt thereof, to the patient in a daily dose of about 40 mg, wherein the improvement of wakefulness is measured on the Scales for Outcomes in Parkinson'"'"'s Disease—

Sleep scale.

9. The method according to claim 8, wherein the improvement of daytime wakefulness is more than 20% compared to baseline after oral administration of pimavanserin, or a pharmaceutically acceptable salt, after 43 days.

10. The method according to claim 8, wherein the improvement of daytime wakefulness is about 29% compared to baseline after oral administration of pimavanserin, or a pharmaceutically acceptable salt, after 43 days.