Compositions for delivery of reboxetine
AssigneeAxsome Therapeutics, Inc.
InventorHerriot Tabuteau
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Abstract
Described herein are methods for the administration of reboxetine, or a pharmaceutically acceptable salt thereof, to a human being in need thereof, resulting in a first maximum plasma concentration and a second maximum plasma concentration, wherein the two maxima are separated by a time period of about 2 hours to about 6 hours.
Claims20
A pharmaceutical product comprising a single dosage form and a label, wherein the single dosage form comprises a first release component and a second release component, wherein the first release component contains 1 mg to 10 mg of reboxetine, and the second release component contains 0.1 mg to 10 mg of reboxetine and is coated with a polymer that delays release of reboxetine in the second release component;
- wherein the single dosage form has a property that, when administered to a fasted human subject:
- 1) the reboxetine in the first release component provides a first local maximum in reboxetine plasma concentration, and
- 2) the reboxetine in the second release component provides a second local maximum in reboxetine plasma concentration,
- wherein the first local maximum in reboxetine plasma concentration occurs about 2 hours to about 6 hours prior to the second local maximum in reboxetine plasma concentration;
- wherein reboxetine is the only active pharmaceutical agent;
- and
- wherein the label states that the single dosage form is to be administered once a day.
Dependencies are inferred from the claim text.