Methods for providing effective reboxetine therapy with once-a-day dosing

• US 6,630,165 B2
• Filed: 02/28/2002
• Issued: 10/07/2003
• Est. Priority Date: 09/15/1999
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Bhatt, Padmanabh P., Desjardin, Michael A., Yam, Noymi V., Lam, Andrew C., Nixon, Phillip R., Seroff, Sylvia L., Edgren, David E., Ayer, Atul D.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Bennett, Rachel M.
• Application Number:
  US10/087,026
• Publication Number:
  US 20020146453A1
• Time in Patent Office: 586 Days
• Field of Search: 424/486, 424/464, 424/468, 424/473, 424/472
• US Class Current: 424/473
• CPC Class Codes: A61K 31/5375 1,4-Oxazines, e.g. morpholine
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Dosage forms and methods for providing sustained release of reboxetine are provided. The sustained release dosage forms provide therapeutically effective average steady-state plasma reboxetine concentrations when administered once per day. This once-a-day dosing regimen results in only one peak plasma reboxetine concentration occurrence in each 24 hour period. In addition, the peak plasma reboxetine concentration occurs at a later time following dose administration and exhibits a lesser magnitude than the peak plasma reboxetine concentration that occurs following administration of reboxetine in an immediate-release dosage form.

Claims

1. A method of treating a condition in a subject responsive to reboxetine, the method comprising orally administering a reboxetine dosage form that produces a steady-state peak plasma reboxetine concentration at a time 4 hours to about 23 hours following dose administration.

2. A method of treating a condition in a subject responsive to reboxetine, the method comprising orally administering reboxetine in a dosage form to produce one peak plasma reboxetine concentration during each 24-hour period.

3. A method of treating a condition in a subject responsive to reboxetine, the method comprising orally administering reboxetine in a dosage form that provides steady-state C_max/dose ratios from about 21 to about 30.