FDA Accepts, Grants Priority Review of NDA for MDMA-Assisted Therapy for PTSD

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The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for midomafetamine capsules (MDMA) intended for use in combination with psychological intervention for individuals with posttraumatic stress disorder (PTSD). The FDA has also granted priority review status to the application, setting a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024. If approved, this will mark the first instance of MDMA-assisted therapy and psychedelic-assisted therapy.¹

Priority review status is granted by the FDA for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared with standard applications.¹

“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,” said Amy Emerson, chief executive officer of Lykos Therapeutics (formerly known as MAPS Public Benefit Corporation), developer of the investigational MDMA-assisted therapy, 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.”

The NDA submission included data from several studies, including 2 randomized, double-blind, placebo-controlled, phase 3 trials (MAPP1 and MAPP2), which evaluated the efficacy and safety of MDMA used alongside psychological intervention compared to placebo with therapy in individuals diagnosed with severe or moderate to severe PTSD, respectively. Both studies met their primary and secondary endpoints, as published in Nature Medicine.^1,2

The primary endpoint assessed changes in PTSD symptom severity using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), while the key secondary endpoint measured improvement in functional impairment associated with PTSD using the Sheehan Disability Scale (SDS). No serious adverse events were reported in the MDMA group in either study.¹

“MDMA is thought to work by reducing the emotional intensity associated with traumatic memories by reconsolidating traumatic memories during psychotherapy in a way that they are stored with less excitatory activation,” Malidelis, Hunt, and Aftab wrote for Psychiatric Times®. “MDMA has also been noted to increase feelings of trust, safety, and empathy, possibly mediated via release of oxytocin and serotonin, which can improve the therapeutic alliance between the therapist and individual.”³

MDMA-assisted therapy for PTSD received Breakthrough Therapy Designation from the FDA in 2017.³ Although the treatment has not yet been approved by any regulatory agency, and the safety and efficacy of this approach for PTSD treatment have not been established, investigational MDMA-assisted therapy is also under study for other indications.¹

Stay up-to-date on news related to research on promising new interventions and developments in the treatment of a wide variety of psychiatric disorders at psychiatrictimes.com.

Note: This article was prepared with the assistance of ChatGPT.

References

1. Lykos Therapeutics announces FDA acceptance and priority review of New Drug Application for MDMA-assisted therapy for PTSD. Lykos Therapeutics. News release. February 9, 2024. Accessed February 13, 2024. https://news.lykospbc.com/2024-02-09-Lykos-Therapeutics-Announces-FDA-Acceptance-and-Priority-Review-of-New-Drug-Application-for-MDMA-Assisted-Therapy-for-PTSD

2. Mitchell JM, Ot’alora G M, van der Kolk B, et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023;29:2473-2480.

3. Malidelis IA, Hunt A, Aftab A. Medication-assisted psychotherapy: the past and future of psychiatry. Psychiatric Times. January 12, 2024. Accessed February 13, 2024. https://www.psychiatrictimes.com/view/medication-assisted-psychotherapy-the-past-and-future-of-psychiatry