US 12,268,686 B2
Transmucosal methods for treating psychiatric and neurological conditions
Peng Li, New Milford, NJ (US); Wei Yao, New Milford, NJ (US); and Robert Davis, San Diego, CA (US)
Assigned to INTRA-CELLULAR THERAPIES, INC., Bedminster, NJ (US)
Filed by INTRA-CELLULAR THERAPIES, INC., New York, NY (US)
Filed on May 17, 2023, as Appl. No. 18/319,425.
Application 18/319,425 is a continuation of application No. 17/338,573, filed on Jun. 3, 2021, granted, now 11,806,347.
Application 17/338,573 is a continuation of application No. 16/900,746, filed on Jun. 12, 2020, granted, now 11,052,083, issued on Jul. 6, 2021.
Application 16/900,746 is a continuation of application No. 15/934,860, filed on Mar. 23, 2018, granted, now 10,716,786, issued on Jul. 21, 2020.
Claims priority of provisional application 62/476,538, filed on Mar. 24, 2017.
Prior Publication US 2023/0301995 A1, Sep. 28, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/498 (2006.01); A61K 9/00 (2006.01); A61K 9/06 (2006.01); A61K 31/4985 (2006.01)
CPC A61K 31/4985 (2013.01) [A61K 9/0036 (2013.01); A61K 9/0043 (2013.01); A61K 9/006 (2013.01); A61K 9/06 (2013.01)] 33 Claims
 
1. A transmucosal pharmaceutical formulation comprising 1-(4-fluoro-phenyl)-4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one (Compound of Formula I) in tosylate salt form; wherein the formulation is a rapidly dissolving tablet or wafer, or a sublingual tablet or wafer, and wherein the formulation comprises from 0.01 to 30 mg of the Compound of Formula I (free base equivalent).