Currently available treatments have failed to address the large unmet need for true once-daily dosing, which 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 60% of people receiving extended-release stimulants for Attention Deficit/Hyperactivity Disorder (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 dosing two to three times per day. Multiple dosing increases the risk of missing doses, resulting in the return of symptoms at inopportune times.
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.
Patients on currently available therapies may report adverse effects or a flare of ADHD symptoms as their medications wear off; these effects are termed “crash” and “rebound”. Using our precise timing, ratio, and style of drug delivery, we believe our candidates provide a controlled descent of blood levels, eliminating this uncomfortable experience for patients.Anxiety
Anxiety disorders are the most common mental health concern in the U.S. (www.nami.org). Anxiety is the feeling of fear that occurs when faced with threatening or stressful situations or can be endogenous and not have an identified stressor. It can be a normal response when confronted with danger, but, if severe and chronic and affects functioning, it could be regarded as an anxiety disorder. An estimated 31 percent of U.S. adults experience an anxiety disorder at some time in their lives.2 People may live with anxiety for years before they are diagnosed or treated. The global COVID-19 crisis has exacerbated the diagnosis and treatment of anxiety and anxiety related disorders and as a result is a priority within the class of unmet medical needs in mental health.