On May 6, 2019, the Food and Drug Administration (FDA) issued a draft guidance for industry titled “Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment.” This guidance is intended specifically to provide developers of stimulant drugs (e.g., methylphenidate and amphetamine) to treat attention deficit hyperactivity disorder (ADHD) with the FDA’s latest thinking regarding developing these products. The FDA provides recommendations in three distinct areas: clinical pharmacology, trial design, and considerations for pregnant patients.
According to the National Institute of Mental Health, ADHD is a disorder that impairs an individual’s ability to pay attention and control impulsive behaviors. Additionally, individuals with ADHD might be overactive and restless. Typically, ADHD symptoms emerge in childhood, then continue into adolescence and into adulthood. ADHD is often treated with medication (e.g., stimulants, non-stimulants, antidepressants) or therapy. In April 2019, the FDA approved the first non-drug treatment for individuals with ADHD aged seven to twelve years old. This newly approved device—the Monarch external Trigeminal Nerve Stimulation System—works by providing mild stimulation to the trigeminal nerve, which transmits this signal into regions of the brain associated with ADHD symptoms including attention, behavior, and emotional responses.