If approved, this would mark the first MDMA-assisted therapy and psychedelic-assisted therapy approved, calling for a reschedule of MDMA from Schedule I. A PDUFA was set for this summer.
The FDA accepted a new drug application (NDA) for midomafetamine capsules [3,4-Methylenedioxy-methamphetamine (MDMA; Lykos Therapeutics)] to be used in combination with psychological interventions, including psychotherapy and other supportive services from a health care provider, for individuals with posttraumatic stress disorder (PTSD). The agency has also granted priority review to the NDA and assigned a prescription drug user fee act target action date of August 11, 2024.1
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"Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD," Amy Emerson, CEO of Lykos, formerly known as Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation, said in a press release. "We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved."1
MAPP1
Trial Name: A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)
ClinicalTrials.gov ID: NCT03537014
Sponsor: Lykos Therapeutics
Completion Date: August 2020
MAPPS2
Trial Name: A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)
ClinicalTrials.gov ID: NCT04077437
Sponsor: Lykos Therapeutics
Completion Date: November 2022
If approved, this would mark the first MDMA-assisted therapy and psychedelic-assisted therapy approved by the agency, calling for a reschedule of MDMA from Schedule I to acknowledge the medical benefits of the drug.1,2
The NDA submission was based on results from the phase 3 studies MAPP1 and MAPP2, which both evaluated the efficacy and safety of MDMA when used in combination with psychological interventions compared with placebo and therapy alone. The studies included individuals with severe (MAPP1) and moderate-to-severe (MAPP2) PTSD. According to the press release, both studies met their primary and secondary endpoints, with the primary endpoint of changes in symptom severity measured by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Secondary endpoints included the improvement in functional impairment associated with PTSD measured by the change in baseline in the Sheehan Disability Scale (SDS).1
Participants were randomly assigned 1:1 to receive either MDMA or the placebo, combined with 3 preparatory and 9 integrative therapy sessions, according to the study authors. They reported that MDMA led to a “significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43).”3 The CAPS-5 scores for those who completed treatment were -24.4 for MDMA and -13.9 for the placebo, according to the results of the study.3
MAPP2 included 104 individuals, 53 of whom received MDMA-assisted therapy and 51 received the placebo plus therapy.4 The investigators of this study noted that 86.5% of those treated with MDMA responded with clinically meaningful improvements at 18 weeks after baseline compared to only 69% of those in the placebo group. The CAPS-5 scores for those who completed treatment were -23.7 for MDMA and -14.8 for the placebo, according to the results of the study.4
Furthermore, neither study reported serious adverse events in the MDMA groups, according to the press release.1
In December 2023, the company submitted a new drug application for MDMA in this indication and Breakthrough Therapy designation was granted by the FDA in 2017.2
MDMA-assisted therapy has not been approved by any regulatory agency, and the safety and efficacy has not been established for the treatment of PTSD. The treatment is also being studied in other indications.1
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