
About Irritability in Autism
You're Not Alone
Seeing your child struggle with irritability is tough. Having them act out and be unable to communicate how they are feeling can be difficult and, at times, heart-wrenching for parents and caregivers. We want you to know that you are not alone. That’s why we are conducting a new clinical trial to learn how an experimental treatment may provide a way to improve irritability associated with autism.

For families of children and adolescents with Autism Spectrum Disorder (ASD), managing and coping with irritability is an ongoing challenge that can have a significant impact on many aspects of daily life.
Understanding Irritability in Autism
According to recent estimates by the Centers for Disease Control and Prevention (CDC), approximately 1 in 44 children has been identified with ASD, a significant increase within the past two decades. ASD is 4 times more prevalent in boys than in girls. Beyond the autism diagnosis, there are numerous co-occurring characteristics that can impact the quality of life of children with autism and their families, among the most common being irritability and anxiety. Irritability manifests in a range of signs and behaviors which can vary for each child and be different depending on the environment, such as at school or at home.
What are some signs of irritability?*
*Adapted from Autism Speaks

Aggression

Self-harming behavior
(such as head banging or harming one’s own body)

Severe tantrums or emotional meltdowns


Property Destruction
(such as breaking one's own toys or possessions)

Need for Isolation
(running away)
Physicians have reported that irritability impacts a majority of pediatric ASD patients. The presentation of ASD-associated irritability can vary with autism severity and age and can be caused by a broad array of different factors including lack of sleep, the inability to communicate pain, and mental health conditions. Currently, there are limited treatment options available for irritability associated with ASD and those that are approved can have significant side effects. Research has shown that certain bacteria in the gut produce substances that may enter the bloodstream and reach the brain, which may contribute to some characteristics often co-occurring with autism, such as irritability. Reducing these substances in the gut before they enter the bloodstream is a potential new approach to treating irritability associated with ASD.
“In studying autism for many years, I have seen many children and their families struggling to manage irritability, anxiety, and other challenges co-occurring with autism. AB-2004 offers potential hope of a new therapeutic option for autism-related irritability that might improve patients’ daily lives by avoiding the side effects and risks of the currently available medications for irritability of autism.”
— Eugene Arnold, M.D., Med, Professor Emeritus, Department of Psychiatry and Behavioral Health, The Ohio State University College of Medicine
