Methods of treatment of schizophrenia

• US 8,980,252 B2
• Filed: 04/20/2012
• Issued: 03/17/2015
• Est. Priority Date: 04/21/2011
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan, Heil, Matthew, Szigethy, James, Fallon, James
• Primary Examiner(s): GITOMER, RALPH J
• Application Number:
  US14/007,793
• Publication Number:
  US 20140127184A1
• Time in Patent Office: 1,061 Days
• Field of Search: 435/94.2, 424/94.21
• US Class Current: 424/94.2
• CPC Class Codes: A61K 38/465 acting on ester bonds (3.1), e.g. lipases, ribonucleases
• CPC Class Codes: A61K 38/47 acting on glycosyl compounds (3.2), e.g. cellulases, lactases
• CPC Class Codes: A61K 38/48 acting on peptide bonds (3.4)
• CPC Class Codes: A61K 38/54 Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
• 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 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: C12Y 301/01 Carboxylic ester hydrolases (3.1.1)
• CPC Class Codes: C12Y 302/01 Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
• CPC Class Codes: C12Y 304/00 Hydrolases acting on peptide bonds, i.e. peptidases (3.4)

Abstract

Described herein are compositions which include digestive enzymes and which are formulated to reduce one or more symptoms of a neuropsychiatric disorder. Also described herein is a method for treating an individual with a neuropsychiatric disorder using digestive enzymes and their derivatives to alleviate the symptoms of neuropsychiatric disorders. The method comprises administering to the individual an effective amount of digestive enzymes that are either naturally or recombinantly derived, or their derivatives, in an amount effective to reduce one or more symptoms of the neuropsychiatric disorder.

Claims

1. A method for treating schizophrenia in an individual in need thereof, comprising administering to the individual a therapeutically effective amount of a pharmaceutical composition comprising digestive enzymes to the individual, wherein the digestive enzymes comprise a protease, an amylase and a lipase, and wherein schizophrenia is treated.

2. The method of claim 1, wherein the individual in need thereof exhibits one or more symptoms selected from the group consisting of one or more positive symptoms, one or more negative symptoms, one or more symptoms of cognitive impairment, and a combination thereof;

wherein;

(a) the one or more positive symptoms comprise hallucinations, delusions, disorganized thought, disorganized speech, movement disorders, bizarre behavior, or a combination thereof;

(b) the one or more negative symptoms comprise loss of motivation, restricted range of emotional experience and expression, reduced hedonic capacity, affective flattening, alogia, avolition, or a combination thereof; and

(c) the one or more symptoms of cognitive impairment comprise poor executive function, inability to use learned information, difficulty paying attention and/or focusing, or a combination thereof.

3. The method of claim 1, further comprising administering one or more additional agents to the individual in need thereof.

4. The method of claim 3, wherein one of said one or more additional agents is an antipsychotic medication.

5. The method of claim 4, wherein said antipsychotic medication is a dopamine antagonist or a serotonin antagonist.

6. The method of claim 1, further comprising providing psychotherapy, vocational rehabilitation, social rehabilitation, or a combination thereof, to the individual in need thereof.

7. The method of claim 1, wherein the pharmaceutical composition is a dosage formulation selected from the group consisting of pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof.

8. The method of claim 7, wherein the dosage formulation further comprises a coating.

9. The method of claim 8, wherein the coating is a lipid coating.

10. The method of claim 1, wherein the pharmaceutical composition comprises amounts of the protease and the lipase (in USP units/dose) in a ratio from about 1:

1 to about 20;

1 of the protease to the lipase and amounts of the protease and the amylase (in USP units/dose) in a ratio from about 1;

0.1 to about 1;

10 of the protease to the amylase.

11. The method of claim 10, wherein the pharmaceutical composition comprises amounts of the protease and the lipase (in USP units/dose) in a ratio from about 4:

1 to about 10;

1 of the protease to the lipase.

12. The method of claim 10, wherein the pharmaceutical composition comprises amounts of the protease and the lipase (in USP units/dose) in a ratio of about 6:

1 of the protease to the lipase.

13. The method of claim 10, wherein the pharmaceutical composition comprises amounts of the protease and the lipase (in USP units/dose) in a ratio of about 1:

1 of the protease to the amylase.