US 11,957,686 B2
Compositions for delivery of reboxetine
Herriot Tabuteau, New York, NY (US)
Assigned to Axsome Therapeutics, Inc., New York, NY (US)
Filed by AXSOME THERAPEUTICS, INC., New York, NY (US)
Filed on Jun. 24, 2022, as Appl. No. 17/848,685.
Application 17/848,685 is a continuation of application No. 17/064,016, filed on Oct. 6, 2020, abandoned.
Application 17/064,016 is a continuation in part of application No. PCT/US2019/037500, filed on Jun. 17, 2019.
Claims priority of provisional application 62/837,002, filed on Apr. 22, 2019.
Claims priority of provisional application 62/688,333, filed on Jun. 21, 2018.
Claims priority of provisional application 62/686,075, filed on Jun. 17, 2018.
Prior Publication US 2022/0313699 A1, Oct. 6, 2022
Int. Cl. A61K 9/20 (2006.01); A61K 9/24 (2006.01); A61K 9/28 (2006.01); A61K 31/5375 (2006.01)
CPC A61K 31/5375 (2013.01) [A61K 9/2013 (2013.01); A61K 9/2027 (2013.01); A61K 9/2054 (2013.01); A61K 9/209 (2013.01); A61K 9/282 (2013.01); A61K 9/2846 (2013.01); A61K 9/2866 (2013.01)] 20 Claims
 
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.