Methods and compositions for treatment of attention deficit disorder

• US 9,028,868 B2
• Filed: 03/23/2012
• Issued: 05/12/2015
• Est. Priority Date: 03/23/2011
• Status: Active Grant

• Current Assignee: Ironshore Pharmaceuticals & Development, Inc.
• Original Assignee: Ironshore Pharmaceuticals & Development, Inc.
• Inventors: Lickrish, David, Zhang, Feng
• Primary Examiner(s): Gulledge, Brian
• Assistant Examiner(s): Cohen, Michael P
• Application Number:
  US13/429,292
• Publication Number:
  US 20120276017A1
• Time in Patent Office: 1,145 Days
• Field of Search: None
• US Class Current: 424/464
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 9/5026 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/5047 Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5073 having two or more different coatings optionally including drug-containing subcoatings
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/14 for treating abnormal movements, e.g. chorea, dyskinesia
• 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 25/26 Psychostimulants, e.g. nicotine, cocaine
• 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: A61P 25/30 for treating abuse or dependence
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 39/00 General protective or antinoxious agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 3 to 8 hours, followed by an ascending release rate.

Claims

1. A method of treating a condition in a subject with a disorder or condition responsive to the administration of a central nervous system stimulant, comprising orally administering an effective amount of an amphetamine, an amphetamine salt, an amphetamine prodrug, or a combination thereof to the subject, wherein the amphetamine, amphetamine salt, amphetamine prodrug, or combination thereof is administered orally in a single delayed release dosage comprising a core comprising a therapeutic amount of a central nervous system stimulant and at least one pharmaceutically acceptable excipient;

a sustained release layer coating the core; and

a delayed release layer coating the sustained release layer, which exhibits (i) a lag period of at least 5 hours during which the plasma concentration of amphetamine, an amphetamine salt, an amphetamine prodrug, or a combination thereof is less than 10% of the maximum concentration (C_max);

(ii) a plasma area under the curve at 10 hours (AUC_0-10) after administration of less than about 7% of AUC_0-48; and

(iii) wherein the time to C_max (T_max) is between 12 and 19 hours after administration.

2. The method of claim 1, wherein the effective amount is administered once a day.

3. The method of claim 1 wherein the amphetamine is amphetamine, a pharmaceutical amphetamine salt, dextroamphetamine or a pharmaceutical salt thereof, or lisdexamfetamine dimesylate, or a pharmaceutical salt thereof.

4. The method of claim 1 wherein Cmax occurs at greater than 15 hours after the administration.

5. The method of claim 1, wherein the disorder or condition is attention deficit disorder, attention deficit hyperactivity disorder, excessive daytime sleepiness, major depressive disorder, bipolar depression, negative symptoms in schizophrenia, chronic fatigue, fatigue associated with chemotherapy or binge eating disorder.

13. The method of claim 1, wherein the disorder or condition is attention deficit disorder or attention deficit hyperactivity disorder.

14. The method of claim 13, wherein the effective amount is from 5 mg-54 mg.

6. A method of treating a condition in a subject with a disorder or condition responsive to the administration of a central nervous system stimulant, comprising orally administering an effective amount of a solid, oral pharmaceutical composition comprising:

a core comprising a therapeutic amount of a central nervous system stimulant and at least one pharmaceutically acceptable excipient;

a sustained release layer coating the core; and

a delayed release layer coating the sustained release layer,

and further wherein when the composition is administered to a human, i) no more than about 10% of the C_max of central nervous system stimulant is detectable in the plasma 5 hours after administration, ii) plasma area under the curve at 10 hours (AUC0.10) after administration is less than about 7% of AUC0-48, and (iii) wherein the time to C_max (T_max) is between 12 and 19 hours after administration.

7. The method of claim 6, wherein the disorder or condition is attention deficit disorder, attention deficit hyperactivity disorder, excessive daytime sleepiness, major depressive disorder, bipolar depression, negative symptoms in schizophrenia, chronic fatigue, fatigue associated with chemotherapy or binge eating disorder.

8. The method of claim 6, wherein the central nervous system stimulant is amphetamine, dextroamphetamine, or an isomer, racemic mixture, prodrug or pharmaceutical salt of any thereof.

9. The method of claim 6, wherein the central nervous system stimulant is amphetamine or a pharmaceutical salt thereof.

10. The method of claim 6, wherein the central nervous system stimulant is dextroamphetamine or a pharmaceutical salt thereof.

11. The method of claim 6, wherein the central nervous system stimulant is lisdexamfetamine dimesylate or a pharmaceutical salt thereof.

12. The method of claim 6, wherein the effective amount is from 5 mg-54 mg.