MAPS Submits NDA for First-Ever Psychedelic-Assisted Therapy for PTSD


Despite affecting 13 million Americans annually, existing post-traumatic stress disorder (PTSD) treatments offer modest relief and more effective approaches are needed.

MAPS Public Benefit Corporation has submitted a new drug application for midomafetamine to treat patients with post-traumatic stress disorder (PTSD).1 It would be indicated to be used in combination with psychological intervention, which includes psychotherapy and other supportive services. If approved, this would be the first psychedelic-assisted therapy for PTSD.

The FDA has previously granted breakthrough therapy designation to midomafetamine, and MAPS PBC has requested the FDA grant priority review of the NDA.

“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,” Amy Emerson, CEO of MAPS PBC, said in a press release.1

PTSD is a mental health condition affecting about 13 million Americans each year, yet currently available treatments only provide modest efficacy. There is an urgent need for effective PTSD therapies. There are high treatment discontinuation rates.

Midomafetamine is an MDMA (3,4-Methylenedioxy-methamphetamine)—commonly known as ecstasy—is a stimulant and psychedelic that is classified as a Schedule I drug by the Drug Enforcement Agency, which means it has the highest potential for abuse and potential to create psychological or physical dependence.

The NDA submission included results from numerous studies including 2 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.

Midomafetamine was studied as an acute treatment that comprised of 3 treatment cycles over a 18-week period. Patients self-administered MDMA under the supervision of a healthcare provider who also provided psychotherapy. This was followed by 3 integration psychotherapy sessions.

MAPP1 and MAPP2 both met the primary endpoint as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-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.2

Results from MAPP2 were published in Nature Medicine in September 2023.2 In the trial, 45 of 52 (86.5%) patients treated with midomafetamine achieved a clinically meaningful benefit, and 37 of 52 (71.2%) patients no longer met criteria for PTSD by study end.

In both trials, treatment was not significantly affected by disease severity, risk of hazardous alcohol or substance use disorder, severe adverse childhood experiences or dissociative subtype. Both studies had a low drop out rate.

No serious adverse events were reported in the MDMA group in both studies. Common treatment-related adverse events included mild increases in blood pressure and pulse. Midomafetamine did not appear to increase the risk of suicidal ideation.

In January 2024, a new reimbursement code will go into effect for psychedelic therapies. The American Medical Association approved in May 2023 a Current Procedural Terminology (CPT) III code for psychedelic therapies.

MAPS and Compass Pathways assisted in the development of the new code. Compass is conducting trials of COMP360, a psilocybin therapy for patients with treatment-resistant bipolar type II disorder. Results were recently published in JAMA Psychiatry, that supports the use of psilocybin in bipolar.3 The company is also conducting ongoing phase 3 trials of COMP360 in treatment-resistant depression. Results from the phase 2 trial in treatment-resistant depression were published in July 2023 in Nature journal, Neuropsychopharmacology.4

This article originally appeared in Formulary Watch.

1. MAPS PBC announces submission of new drug application to the FDA for MDMA-assisted therapy for PTSD. News release. MAPS Public Benefit Corporation. December 12, 2023. Accessed December 12, 2023.
2. 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. 2021;27(6):1025-1033. doi:10.1038/s41591-021-01336-3
3. Aaronson ST, van der Vaart A, Miller T, et al. Single-dose synthetic psilocybin with psychotherapy for treatment-resistant bipolar type II major depressive episodes: A nonrandomized controlled trial. JAMA Psychiatry. Published online December 6, 2023. doi:10.1001/jamapsychiatry.2023.4685
4. Goodwin GM, Croal M, Feifel D, et al. Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication. Neuropsychopharmacol. 2023;48(10):1492-1499. doi:10.1038/s41386-023-01648-7
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