Israeli Ministry of Health Approves MDMA/PTSD Study
On June 1, 2011, Israel’s Ministry of Health approved our Israeli study of MDMA-assisted psychotherapy for PTSD. This approval indicates that the Ministry was satisfied with our response to their April 28 request for additional information. Now that the study has the full approval of Israeli regulatory bodies, we have begun preparing to submit the protocol to the US FDA, which must prospectively approve the study before we can start enrolling subjects since it is being conducted under a US Investigational New Drug application. The study initiation will take place in approximately one month, during which time we will finalize the study insurance documents and contracts with the study site. Training materials containing the measures to be used in the study have been provided to the investigators and independent raters, and we continue working with clinical research organization Antaea Medical Services, Ltd., to prepare the remaining documents and forms.