ABSTRACT
The development of atomoxetine hydrochloride (Stratteraw) involved several
important factors. In addition to demonstrating efficacy in attention-deficit/ hyperactivity disorder (ADHD), key aspects of development included the poly-
morphic metabolism of atomoxetine by cytochrome P450 2D6 (CYP2D6)
and the primary target population being children. Dose optimization was a
critical part of the successful development of atomoxetine and employed
phase-appropriate development strategies. Earlier clinical studies focused on
dose optimization related to the safety and tolerability of atomoxetine, and
also defining the impact of the CYP2D6 polymorphism on the general dis-
position of the molecule. Later clinical studies focused on dose optimiza-
tion of atomoxetine related to efficacy measures, and the potential necessity
of individualizing dosing based on genotype. This chapter presents only a
subset of the data available for Strattera, and, therefore, complete safety,
efficacy, and dosing information should be obtained from the current
package insert.
