MAPS Receives Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD, Will Use Medrio in Upcoming Related Clinical Trials

With the support of an EDC like Medrio, we feel poised to maximize our chances of success in these endeavors.

Medrio, a Software as a Service (SaaS) company providing cutting-edge eClinical technology to clinical trials, has announced that one of its customers, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), has acquired Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for MDMA for the treatment of posttraumatic stress disorder (PTSD). MAPS and the FDA have also reached an agreement under the Special Protocol Assessment Process for the design of two upcoming Phase III trials of MDMA-assisted psychotherapy for patients with severe PTSD. MAPS will use Medrio for its clinical data management in these trials.

The decision to grant Breakthrough Therapy Designation signals that the FDA acknowledges that MDMA may be superior, both in terms of efficacy and from a regulatory standpoint, to available medications for PTSD. PTSD is a serious, long-lasting, and life-threatening condition when not adequately treated, highlighting the need for expedited approval of new therapies. A newly published article in the Washington Post offers additional information on the announcement and its implications.

For the trials, MAPS will utilize a wide range of modules in Medrio’s software, including eSource, dictionary coding, and others. MAPS has used Medrio for clinical data management in previous trials, and their selection of Medrio for these upcoming Phase III trials is a result of the software’s consistent and demonstrated ability to deliver numerous benefits to researchers at MAPS. The Medrio features particularly pleasing to MAPS include, but are not limited to:

  • Ease of…

Read the full article at the Original Source..

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