Autistic Disorder has a 12-month prevalence of ~1.5% and affects approximately 3.8 million people in the US 


Autism Spectrum Disorder (ASD) is a lifelong developmental disability characterized by limited social interaction and communication skills, stereotyped and repetitive behaviors, and a low interest in activities or play. Initial signs and symptoms are typically apparent in the early developmental period, however social deficits and behavioural patterns may not be recognized as symptoms of ASD until a child is unable to meet social, educational, occupational, or other important life stage milestones. Functional limitations vary among persons with ASD and might develop over time.

The prevalence of ASD has increased significantly in recent years, with most recent estimates between 1% - 2% of all children. The underlying reasons for the apparent increase in prevalence have been difficult to study empirically, however it is suggested to be the result of multiple factors, including: greater awareness and recognition of, an expansion in the diagnostic criteria and increased services available for patients and caregivers. 


Current Treatment

Treatments for the core symptoms of Autistic Disorder are typically focused on non-pharmacologic options such as Psychological Interventions, Speech Therapy, Occupational Therapy, Pivotal Response Treatment (ABA-based therapy) and dietary and nutritional interventions. There are limited prescription medications approved in pediatric patients. Atypical antipsychotics as a class have demonstrated effectiveness in managing behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. Aripiprazole and risperidone are the two FDA-approved atypical antipsychotics for irritability associated with Autistic Disorder. Approximately 56% of children with ASD use at least one psychotropic medication.


Unmet Medical Needs

Adherence to treatment varies by the type of intervention that is implemented. Behavioural and developmental treatments, for example, may have a greater impact on family routines, require greater resources to implement and have been associated with lower adherence rates compared to pharmacotherapy. Despite this, medication adherence in the pediatric ASD population remains a significant challenge, with estimated medication adherence to antipsychotics at a rate of 52%. A once-weekly transdermal alternative could address this challenge by improving ease of administration for both patients and caregivers.