发明名称 |
Methods of treatment of attention deficit hyperactivity disorder |
摘要 |
Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 5 to 7 hours or longer, followed by an ascending release rate. When administered at night the composition provides early morning improvement in symptoms of ADHD and sustained improvement over a period of at least 12 hours. |
申请公布号 |
US9603809(B2) |
申请公布日期 |
2017.03.28 |
申请号 |
US201514716777 |
申请日期 |
2015.05.19 |
申请人 |
Ironshore Pharmaceuticals & Development, Inc. |
发明人 |
Lickrish David;Zhang Feng |
分类号 |
A61K9/50;A61K31/4458 |
主分类号 |
A61K9/50 |
代理机构 |
Vinson & Elkins L.L.P. |
代理人 |
Vinson & Elkins L.L.P. |
主权项 |
1. A method of treating a condition in a subject with a disorder or condition responsive to the administration of a methylphenidate, comprising orally administering an effective amount of methylphenidate or a pharmaceutical salt thereof in a formulation comprising a core comprising methylphenidate or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient; a sustained release layer enclosing the core and a delayed release layer enclosing the sustained release layer, wherein when the formulation is administered to a human subject in a fasted state, there is (i) a lag of at least 7 hours during which the plasma concentration of methylphenidate is less than 5% of the maximum plasma (Cmax), (ii) a plasma area under the curve at 10 hours (AUC0-10) after administration that is less than about 7% of AUC0-48; and (iii) a time to Cmax (Tmax) between 12 and 19 hours after administration, and wherein administration to a population of subjects with ADHD provides a significant improvement in ADHD related behavior or cognitive ability over a period of at least 12 continuous hours as measured by a validated rating scale. |
地址 |
Camana Bay KY |