Social Anxiety in Autistic Adults: Amended Protocol and Response Documents Submitted to FDA

On June 4, 2013, we submitted to the FDA the amended protocol for our planned study of MDMA-assisted therapy for social anxiety in autistic adults, along with a detailed response to the April 30 Advice Letter from the FDA. The FDA approved the protocol design on April 30, requesting several changes to how long prior to the study subjects must stop taking other psychiatric medications and to the exclusion criteria. The amended protocol incorporates the changes about subject medications; we also submitted a response letter explaining we do not believe the exclusion criteria changes are necessary. Once the FDA has reviewed and approved an amended protocol, we will submit the protocol, informed consent form, and study materials for review by the Institutional Review Board at Harbor-UCLA Medical Center/Los Angeles Biomedical Research Institute.