MAPS PBC Announces Submission of New Drug Application to the FDA for MDMA-Assisted Therapy for PTSD

• Filing marks first NDA submission for any psychedelic-assisted therapy 
• Submission represents 30 plus years of clinical research into potential use of MDMA-assisted therapy for PTSD
• NDA includes two Phase 3 trials (MAPP1 and MAPP2) that both met primary and secondary endpoints

SAN JOSE, Calif., Dec. 12, 2023 /PRNewswire/ -- MAPS Public Benefit Corporation ("MAPS PBC"), a clinical-stage company dedicated to changing the way mental health conditions are treated, announced the submission of a new drug application ("NDA") to the U.S. Food and Drug Administration ("FDA") for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider. This investigational MDMA-assisted therapy is in development for individuals with post-traumatic stress disorder ("PTSD") and, if approved, would be the first psychedelic-assisted therapy.

"The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades," said Amy Emerson, chief executive officer, MAPS PBC. "If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health."

The NDA submission included results from numerous studies including two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA-assisted therapy versus placebo with therapy in participants diagnosed with moderate or moderate and severe PTSD, respectively. Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in Nature Medicine.^1,2   

With Breakthrough Therapy designation given to MDMA in 2017, MAPS PBC has requested the FDA grant Priority Review of the NDA. The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively). If approved by the FDA, the U.S. Drug Enforcement Agency ("DEA") would be required to reschedule MDMA making it available for prescription medical use.

Phase 3 Results^1,2
MAPP1 and MAPP2 both met the primary endpoint as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 ("CAPS-5") and the key secondary endpoint of improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale ("SDS"). No serious adverse events were reported in the MDMA group in both studies.

MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD. Investigational MDMA-assisted therapy is also being studied in other indications. 

About MDMA-Assisted Therapy
MDMA-assisted therapy is an investigational treatment being studied using a combination of MDMA, psychotherapy (also known as talk therapy) and other supportive services to treat PTSD. MAPS PBC completed six Phase 2 and two Phase 3 studies examining the use of investigational MDMA-assisted therapy for PTSD. Investigational MDMA-assisted therapy was studied as an acute treatment that comprised of three treatment cycles over a twelve-week period. Each investigational treatment cycle consisted of one medication session and three integration sessions. During the medication sessions a patient self-administered MDMA under the supervision of at least one qualified healthcare provider who provided psychotherapy and other supportive services. This was followed by three integration psychotherapy sessions to process what was uncovered. Prior to the 12 weeks, there were three preparatory sessions.

History of MDMA
MDMA (3,4-Methylenedioxy-methamphetamine) is an entactogen—a class of psychoactive drugs that produce experiences of emotional communion, oneness, relatedness, emotional openness and is thought to have use for various medical conditions.³ In the 1960's and 1970's MDMA was used in conjunction with psychotherapy by mental health providers to enhance patients' ability to process difficult emotions and experiences.⁴ In 1985, the DEA made MDMA a Schedule I drug under the Controlled Substances Act preventing it from being used for medical use.⁵ It wasn't until the 2000's when placebo-controlled studies were conducted examining the safety and efficacy data on the use of MDMA-assisted therapy for treatment-resistant PTSD⁶.

ABOUT PTSD
PTSD is a mental health condition affecting approximately 13 million Americans each year⁷, yet currently available treatments only provide modest efficacy.⁸ People with PTSD can experience debilitating symptoms that impact nearly all areas of a person's life.⁹ They also frequently experience comorbidities including anxiety, depression and substance use disorder.¹⁰ PTSD has an enormous economic impact resulting in an annual burden of over $200 billion.¹¹ There are high treatment discontinuation rates¹² underscoring the urgent need for novel and effective PTSD therapies.

ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) envisions a world where mental health care is significantly better. With a mission to transform mental health care, MAPS PBC is focused on developing novel treatments. In 2014, MAPS, a 501(c)(3) non-profit organization, created MAPS PBC as a for-profit public benefit corporation to continue the research and education around the development of investigational MDMA-assisted therapy. For more information, please visit www.mapsbcorp.com and connect with the company on LinkedIn and Facebook.

MEDIA CONTACT
E. Blair Clark-Schoeb
Chief Communications Officer
[email protected] 

¹ Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med 609 2021;27:1025–33
² Mitchell JM, Ot'alora MG et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023 Sept 14 doi: 10.1038/s41591-023-02565-4. Online ahead of print. 
³ O'Neil, M.J., The Merck Index: An Encyclopedia of chemicals, drugs and biologicals. Merck Research Laboratories, Merck and Co. Inc, Whitehouse station, New Jersey, 2006. 319
⁴ Wagner MT, Mithoefer MC, Mithoefer AT, MacAulay RK, Jerome L, Yazar-Klosinski B, Doblin R. Therapeutic effect of increased openness: Investigating mechanism of action in MDMA-assisted psychotherapy. J Psychopharmacol. 2017 Aug;31(8):967-974. doi: 10.1177/0269881117711712. Epub 2017 Jun 21. PMID: 28635375; PMCID: PMC5544120.
⁵ National Institute on Drug Abuse What is the history of MDMA? | National Institute on Drug Abuse (NIDA) (nih.gov). Accessed, September 8, 2023. What is the history of MDMA? | National Institute on Drug Abuse (NIDA) (nih.gov)
⁶ Mithoefer et al., 2011; Oehen et al., 2013.
⁷ VA National Center for PTSD. US Department of Veterans Affairs. Accessed November 29, 2023. https://www.ptsd.va.gov/understand/common/common_adults.asp
⁸ Morina N. Remission from post-traumatic stress disorder in adults: a systematic review and meta-analysis of long term outcome studies. Clin Psychol Rev. (2014) Apr;34(3):249-55. doi: 10.1016/j.cpr.2014.03.002.
⁹ The Mayo Clinic, PTSD, Symptoms and Causes www.mayoclinic.org/diseases-conditions/post-traumatic-stress-disorder/symptoms-causes/syc-20355967c
¹⁰ Grinage B.D. Diagnosis and Management of Post-traumatic Stress Disorder. Am Fam Physician. (2003);68(12):2401-2409.
¹¹ Davis LL. The economic burden of posttraumatic stress disorder in the United States from a societal perspective. J Clin Psychiatry. (2022) Apr 25;83(3):21m14116. doi: 10.4088/JCP.21m14116.
¹² Varker T. Dropout from guideline-recommended psychological treatments for posttraumatic stress disorder: A systematic review and meta-analysis. Journal of Affective Disorders Reports (2021) Apr 2021, 100093. doi: 10.1016/j.jadr.2021.100093 

SOURCE MAPS Public Benefit Corporation