Patent ID: 9028868
Filing Date: 2015-05-12
Classification: A61K,A61P

Abstract:
1. A method of treating a condition in a subject with a disorder or condition responsive to the administration of a central nervous system stimulant, comprising orally administering an effective amount of an amphetamine, an amphetamine salt, an amphetamine prodrug, or a combination thereof to the subject, wherein the amphetamine, amphetamine salt, amphetamine prodrug, or combination thereof is administered orally in a single delayed release dosage comprising a core comprising a therapeutic amount of a central nervous system stimulant and at least one pharmaceutically acceptable excipient; a sustained release layer coating the core; and a delayed release layer coating the sustained release layer, which exhibits (i) a lag period of at least 5 hours during which the plasma concentration of amphetamine, an amphetamine salt, an amphetamine prodrug, or a combination thereof is less than 10% of the maximum concentration (C max ); (ii) a plasma area under the curve at 10 hours (AUC 0-10 ) after administration of less than about 7% of AUC 0-48 ; and (iii) wherein the time to C max (T max ) is between 12 and 19 hours after administration.