Stimulants are the most commonly prescribed class of medications for ADHD. These medications are believed to work by enhancing the effects of dopamine and norepinephrine neurotransmitters in the brain and have a robust research base supporting their effectiveness in treatment of attention deficit disorder. Companies continue to develop stimulant-based extended release products.
In contrast, non-stimulant medications are typically second line or adjunctive therapy in the treatment of ADHD. Compared to stimulants they tend to be less efficacious and have a slower onset of action in addition to their own unique set of side effects including decreased appetite, nausea, vomiting, fatigue, dyspepsia (indigestion), dizziness, and mood swings.
Even with the advent of extended release stimulants, no single ADHD product available today works quickly, lasts the entire active day, minimizes negative side effects caused when medicine wears off during the active day, and allows lasting sleep. Common side effects of current best-in-class ADHD stimulant drugs include sleeplessness and symptoms of feeling extremely restless, very irritable, or tired, sad and subdued after blood API levels drop below the therapeutic levels during the active day.
There is a large unmet need for true once-daily dosing. A once-daily dosing strategy has the potential for patient/caregiver convenience and is also designed to improve patient compliance, therapeutic efficacy, inappropriate dosing of short acting stimulants and cost. Up to 50% of people receiving extended release stimulants for ADHD need short acting “boosters” to maintain therapeutic blood levels through the afternoon and evening hours and/or to initiate treatment in the morning. Others need either 2 or 3 times a day dosing. Multiple dosing increases the risk of missing doses, which results in the return of symptoms at inopportune times.