Method and composition for administering an NMDA receptor antagonist to a subject

• US 7,619,007 B2
• Filed: 11/22/2005
• Issued: 11/17/2009
• Est. Priority Date: 11/23/2004
• Status: Active Grant

• Current Assignee: Adamas Pharma, LLC (Supernus Pharmaceuticals, Inc.)
• Original Assignee: Adamas Pharmaceuticals, Inc. (Supernus Pharmaceuticals, Inc.)
• Inventors: Went, Gregory T., Fultz, Timothy J., Meyerson, Laurence R.
• Primary Examiner(s): Padmanabhan; Sreeni
• Assistant Examiner(s): Carter; Kendra D
• Application Number:
  US11/285,905
• Publication Number:
  US 20060142398A1
• Time in Patent Office: 1,456 Days
• Field of Search: 514/455, 514/662, 514/740, 514/964, 424/468
• US Class Current: 514/662
• CPC Class Codes: A61K 31/13 Amines A61K31/04 takes precedence
• CPC Class Codes: A61K 9/4891 Coated capsules; Multilayered drug free capsule shells with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/08 Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• 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
• CPC Class Codes: A61P 25/30 for treating abuse or dependence

Abstract

The invention provides methods and compositions for administering an NMDA receptor antagonist (e.g., memantine) to a subject.

Claims

1. A method of administering memantine to a human subject in need thereof, comprising 10-100 mg of:

orally administering to the human subject once per day over multiple days a sustained release oral dosage form comprising memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of the memantine or salt thereof, wherein a therapeutically effective daily dose of the memantine or salt thereof is administered from initiation of therapy without prior dose escalation of memantine, and wherein the subject has a condition selected from the group consisting of Alzheimer'"'"'s disease, dementia, Parkinson'"'"'s disease, and neuropathic pain.

2. The method of claim 1, wherein the sustained release component comprises a sustained release coating.

3. The method of claim 1, wherein the sustained release component comprises a sustained release matrix.

4. The method of claim 1, wherein the sustained release component comprises a sustained release coating and a sustained release matrix.

5. The method of claim 1, wherein the sustained release oral dosage form further comprises a delayed release component.

6. The method of claim 1, wherein the dosage form comprises a capsule or a tablet.

7. The method of claim 1, wherein the condition is dementia.

8. The method of claim 7, wherein the dementia is Alzheimer'"'"'s disease dementia.

9. The method of claim 1, wherein the dosage form comprises 10-50 mg of memantine or salt thereof.

10. The method of claim 1, wherein the dosage form comprises at least 22.5 mg of memantine or salt thereof

11. In a method of avoiding side-effects in a human subject initiating memantine therapy, the improvement comprising orally administering to the subject once per day over multiple days a sustained release oral dosage form comprising 10-100 mg of memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of the memantine or salt thereof, wherein a therapeutically effective daily dose of the memantine or salt thereof is administered from initiation of therapy without prior dose escalation of memantine, and wherein the subject has a condition selected from the group consisting of Alzheimer'"'"'s disease, dementia, Parkinson'"'"'s disease, and neuropathic pain.

12. The method of claim 11, wherein the sustained release component comprises a sustained release coating.

13. The method of claim 11, wherein the sustained release component comprises a sustained release matrix.

14. The method of claim 11, wherein the sustained release component comprises a sustained release coating and a sustained release matrix.

15. The method of claim 11, wherein the sustained release oral dosage form further comprises a delayed release component.

16. The method of claim 11, wherein the dosage form comprises a capsule or a tablet.

17. The method of claim 11, wherein the condition is dementia.

18. The method of claim 17, wherein the dementia is Alzheimer'"'"'s disease dementia.

19. The method of claim 11, wherein the dosage form comprises 10-50 mg of memantine or salt thereof.

20. The method of claim 11, wherein the dosage form comprises at least 22.5 mg of memantine or salt thereof.