FDA guidance for industry on ADHD developing stimulant drugs

The US Food and Drug Administration on Friday published the draft guidance for industry, Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment, to provide general recommendations to companies developing stimulant drugs for treatment of ADHD in pediatric and adult patients.

ADHD is a common disorder that begins in childhood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and very high levels of activity. ADHD can impact a person’s family, social, academic and work life. Stimulant drugs (eg, methylphenidate and amphetamine) are the most commonly prescribed medications for the treatment of ADHD.

The draft guidance explains that, because ADHD is a disorder that begins in childhood, a new drug application for any drug intended to treat ADHD should include data from adequate and well-controlled studies in pediatric patients. Additionally, the draft guidance provides information on clinical trial designs and describes the types of data that would be expected to demonstrate safety and effectiveness under different types of FDA approval pathways.