Drugs in Clinical Development for Attention-Deficit/Hyperactivity Disorder: Summary and Table
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Drugs in Clinical Development for Attention-Deficit/Hyperactivity Disorder: Summary and Table
Ó Springer International Publishing Switzerland 2013
Given the importance of pharmacotherapy for effective attention-deficit/hyperactivity disorder (ADHD) management, there is a need for safe and effective drugs, particularly for difficult-to-treat patients. The most promising pharmacological agents target noradrenergic neurotransmission and dopamine-mediated catecholamine action to improve prefrontal cortex (PFC) function—particularly attention and impulse control—via direct simulation of the noradrenergic a2-receptors (e.g. methylphenidate) or indirectly via increased endogenous noradrenaline and dopamine and their action on noradrenergic and dopaminergic receptors (e.g. atomoxetine). Drugs with greater potency in the PFC relative to subcortex have a lower risk of abuse. Therefore, drug development efforts are focused in these areas. Following the success of atomoxetine, the oral selective noradrenergic reuptake inhibitor (SNRI) edivoxetine is in phase II/III development for ADHD in children. Other particular areas of research include the development of extended-release formulations (e.g. the oral pyrrolidinone metadoxine extended-release, in phase II for use in adults and children) or for easier administration in children or those unable to swallow such as transdermal formulations (e.g. amfetamine transdermal, in phase II in children/adolescents, and ND 0801 transdermal patch containing nicotine-receptor agonist and a nicotinic acetylcholine desensitization inhibitor, in phase I/II in adults) or as palatable tablets (e.g. methylphenidate extendedrelease chewable tablets, in phase III) or an orally disintegrating tablet (e.g. controlled release amfetamine polistyrex [NT0202] currently in preregistration). Another small molecule, bavisant, is in phase I ADHD development in children and adolescents and phase II in adults.
Antipsychotics—dopamine D2 receptor antagonist molidone and D2 partial agonist brexpiprazole—are also being investigated for treatment of ADHD in children. Oral extended-release molindone is in phase IIb/III for ADHD with comorbid aggression, and an immediate-release formulation is in phase IIa development for children with ADHD and persistent serious conduct problems. Brexpiprazole is in phase II development as adjunctive therapy for ADHD in adults with an incomplete response to stimulants. Other agents in phase II clinical development for ADHD include an oral monoamine reuptake inhibitor TD 9855—a dual noradrenergic and serotonin reuptake inhibitor with modest selectivity for norepinephrine over serotonin—and SEP 225289—a serotonin, noradrenergic and dopamine reuptake inhibitor—under investigation in adults with ADHD. In addition, the SNRI SPN 812 is in phase I/II in adults with ADHD. In France, the histamine H3 agonist pitolisant is under development for treatment of CNS disorders including ADHD. A small phase II trial was expected to be completed in 2010 but no recent activity h
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