Patent ID: 11957686
Assignee: AXSOME THERAPEUTICS, INC.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 0:
1. 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.