Researchers at the University of North Carolina School of Medicine needed testing, scale-up and manufacturing of intra-nasally administered Oxytocin for a clinical study involving children with Autism. The research, funded by NICHD (National Institute of Child Health and Human Development), originally involved a commercial pharmaceutical company. When the company decided to pull out of the study, researchers needed to find an alternative that met the requirements of the NIH and FDA.
Autism affects 1 in 68 American children, according to the Center for Disease Control (CDC). This estimate has grown 30% since 2012, when it was estimated that 1 in 88 children would have autism.