Unmet Medical Need

Adult ADHD represents a relatively untreated condition. In adults, the hyperactive component is less pronounced and the attention deficit a larger treatment issue than in adolescents. ADHD is not just a lifestyle condition in that inattention and impulsivity result in significant functional impairment and have negative occupational and interpersonal consequences. Impulsivity and the resulting impaired risk assessment also contribute to a higher incidence of illicit drug use among ADHD patients.

From a research perspective, there is a need for objective diagnostic tools and indicators to predict which drug will be the most effective therapy for a given patient. Approximately 70% of children with ADHD respond positively to stimulants as first-line therapy. Additionally, roughly two-thirds of children who do not respond to the first stimulant usually respond to another type (i.e., Adderall or methylphenidate, or vice versa). Hence, the total response rate appears to be about 90%. Overall, studies indicate that multiple unrelated pharmacological agents are efficacious in treating ADHD across the lifespan, with efficacious agents sharing noradrenergic and dopaminergic mechanisms of action. Stimulants are most effective in reducing the hyperactivity in ADHD but less effective in addressing some of the working memory, organization, and planning (i.e., 'executive function') deficits characteristic of ADHD.94 Research also suggests that the impulsivity and/or aggression associated with this condition are often suboptimally treated with existing therapies.

Key additional areas of unmet need for the treatment of ADHD include stimulant-like efficacy on hyperactivity in a nonscheduled agent, improved efficacy on impulsivity/aggression, alternative therapies for stimulant nonresponders, therapeutics that do not affect growth, sleep, and appetite, nonstimulants without a risk for abuse, and once-daily formulations.

Table 2 Summary of some drugs in development for the treatment of ADHD




Mechanism of action




Phase I

DA, NE, 5-HT reuptake

Active metabolite of

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