IN FY20, MAPS' PRIMARY FOCUS WAS ON COMPLETING ITS FIRST OF TWO MULTI-SITE PHASE 3 CLINICAL TRIALS OF MDMA-ASSISTED PSYCHOTHERAPY FOR PTSD, WHICH BEGAN RECRUITMENT IN NOVEMBER 2018 AT 15 SITES (11 IN THE US, 2 IN ISRAEL AND 2 IN CANADA) AND COMPLETED GATHERING THE FINAL DATA POINT IN AUGUST 2020. DUE TO COVID, WE CAME TO AGREEMENT WITH FDA TO ENROLL 90 INSTEAD OF 100 VOLUNTEERS WITH CHRONIC, SEVERE PTSD. VOLUNTEERS WERE AT LEAST 18 YEARS OLD AND IN GOOD PHYSICAL HEALTH TO PARTICIPATE. THIS WAS BE THE FIRST OF TWO PHASE 3 TRIALS OF MDMA-ASSISTED PSYCHOTHERAPY FOR PTSD CONDUCTED UNDER U.S. FOOD AND DRUG ADMINISTRATION (FDA) GUIDELINES. IN FY 20, WE ALSO LAID THE GROUNDWORK TO BEGIN THE SECOND PHASE 3 TRIAL WHICH WILL ENROLL AN ADDITIONAL 100 PARTICIPANTS. IN FY20, MAPS CONDUCTED DISCUSSIONS WITH REGULATORY AGENCIES IN MULTIPLE COUNTRIES IN EUROPE TO OBTAIN APPROVAL FOR PHASE 2 THERAPIST TRAINING PROTOCOLS AS A PREREQUISITE FOR INITIATING PHASE 3 STUDIES SEEKING APPROVAL FROM THE EUROPEAN MEDICINES AGENCY (EMA). EUROPEAN TRIALS ARE PLANNED TO START IN FY21.IN LATE DECEMBER 2017, MAPS BEGAN PRELIMINARY, PROMISING DISCUSSIONS WITH FDA AND DEA ABOUT THE ESTABLISHMENT OF A SPECIAL EXPANDED ACCESS PROGRAM, ALSO KNOWN AS COMPASSIONATE USE. THIS EXPANDED ACCESS PROGRAM ALLOWS TREATMENT-RESISTANT PATIENTS TO USE AN INVESTIGATIONAL TREATMENT ON A COMPASSIONATE BASIS AT THEIR OWN RISK AND AT THEIR OWN COST WHILE THE PHASE 3 STUDIES FOR THAT TREATMENT ARE STILL ONGOING. THE PROGRAM IS DESIGNED TO ADDRESS URGENT AND LIFE-THREATENING CONDITIONS IN PATIENTS WHO HAVE CURRENTLY FAILED TO OBTAIN RELIEF WITH EXITING TREATMENT OPTIONS. MAPS LEARNED THAT FDA APPROVES OVER 98% OF APPLICATIONS FOR EXPANDED ACCESS AND DEA INDICATED THAT IT WOULD BE WILLING AND ABLE TO REVIEW SCHEDULE 1 LICENSE APPLICATIONS FROM 100 OR MORE APPLICATIONS FOR EXPANDED ACCESS SITES. IN THE FIRST FEW MONTHS OF 2019, MAPS SUBMITTED ITS EXPANDED ACCESS PROTOCOL TO FDA FOR REVIEW, BUT THE STUDY WAS PLACED ON CLINICAL HOLD. MAPS ENGAGED IN FURTHER DISCUSSIONS WITH FDA, BUT IT WASN'T UNTIL FY20 THAT FDA APPROVED MAPS' EXPANDED ACCESS PROTOCOL FOR 50 SUBJECTS WITH TREATMENT-RESISTANT PTSD.IN FY 20, MAPS ENROLLED ADDITIONAL THERAPISTS IN OUR THERAPIST TRAINING PROTOCOL, MT1. IN THIS PROTOCOL, THERAPISTS IN OUR TRAINING PROGRAM CAN VOLUNTEER TO RECEIVE MDMA IN A THERAPEUTIC SETTING ADMINISTERED BY TWO CO-THERAPISTS FROM OUR THERAPIST TRAINING TEAM.IN FY 20, ADDITIONAL THERAPISTS IN OUR TRAINING PROGRAM COMPLETED THEIR FINAL STAGE OF TRAINING BY TREATING ONE PTSD PATIENT IN AN OPEN-LABEL PROTOCOL PROVIDING THE SAME TREATMENT DESIGN AS IN OUR PHASE 3 STUDY. MAPS' THERAPIST TRAINING TEAMS VIEWED VIDEOTAPES OF THE THERAPY SESSIONS AND PROVIDED SUPERVISION AND FEEDBACK TO THE THERAPISTS ON HOW WELL THEY WERE ADHERING TO OR TREATMENT MANUAL FOR MDMA-ASSISTED PSYCHOTHERAPY FOR PTSD. MARIJUANA RESEARCH WAS COMPLETED IN FY19 AND IN FY 20 WE WORKED TO OBTAIN PUBLICATION OF OUR RESEARCH IN A PEER-REVIEWED JOURNAL WITH THAT PEER-REVIEW PROCESS EXTENDING INTO FY21. IN FY20, MAPS ALSO WORKED TO DEVELOP A NEW MARIJUANA/PTSD PROTOCOL TO BUILD ON THE RESULTS OF OUR FIRST MARIJUANA/PTSD PROTOCOL. IN FY16, AFTER SEVEN YEARS OF STRUGGLE, MAPS FINALLY RECEIVED DEA AND IRB APPROVAL TO MOVE FORWARD WITH ITS STUDY EXAMINING THE EFFICACY OF SMOKED MARIJUANA IN 76 VETERANS WITH CHRONIC, TREATMENT-RESISTANT PTSD. THIS RESEARCH WAS FUNDED BY A $2.156 MILLION GRANT FROM THE COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT (CDPHE). IN FEBRUARY 2017, THE FIRST PARTICIPANT WAS ENROLLED AND RECEIVED CANNABIS.Multidisciplinary Assoc is a small health care company based in the United States with only 32 employees and an annual revenue of $21.9M.
Multidisciplinary Assoc's mission statement
Founded in 1986, the Multidisciplinary association for psychedelic studies is a 501 non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.
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