Psychiatry Month in Review: June 2024

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This month in review captures the top FDA updates, including the first FDA Advisory Committee meeting to discuss the NDA for a psychedelic-assisted therapy.

June was a monumental month for US Food and Drug Administration (FDA) updates in psychiatry. The highly anticipated FDA Psychopharmacologic Advisory Committee to vote on the effectiveness of MDMA-assisted therapy for PTSD took place the first Tuesday of the month, marking the first FDA discussion on a New Drug Application (NDA) for psychedelic-assisted therapy. The FDA also accepted a supplemental NDA (sNDA) application for brexiprazole adjunctive therapy for adult PTSD.

This month in review captures the top 4 FDA and pipeline updates.

FDA Updates in Psychiatry

FDA Accepts sNDA for Brexpiprazole in Combination with Sertraline for Adult PTSD

The FDA accepted the supplemental NDA (sNDA) filing for brexpiprazole in combination with sertraline for the treatment of adult PTSD, announced by Otsuka and Lundbeck on June 25, 2024. The Prescription Drug User Fee Act (PDUFA) target action data for the completion of the review is February 8, 2025.

The sNDA submission package includes 3 randomized, double-blind, active-controlled trials evaluating the safety and efficacy of brexpiprazole in combination with sertraline in adults with PTSD. The flexible dose trials showed brexpiprazole with sertraline was linked to a significant reduction in PTSD symptoms (P < .05).

FDA Psychopharmacologic Advisory Committee Votes Against Supporting Effectiveness of MDMA for PTSD

On June 4, 2024, the FDA Psychopharmacologic Advisory Committee (PDAC) voted 2 – 9 against supporting the effectiveness of MDMA in the treatment of adult patients with PTSD. The decision is likely to influence the final FDA decision on Lykos Therapeutics’ NDA for MDMA-assisted psychotherapy, which is scheduled mid-August this year.

The NDA submission package, including trial data from MAPP1 and MAPP2, marked as the first NDA submission for any psychedelic-assisted therapy. Both trials met their primary endpoint of change from baseline in Clinician-Administered PTSD Scale for DSM-5.

HCPLive spoke with Franklin King, MD, from Massachusetts General Hospital, in a live report following the FDA PDAC Meeting.

Bessel van der Kolk, MD: What MDMA-Assisted Therapy Taught Us About PTSD

Bessel van der Kolk, MD: The Future of MDMA Assisted Therapy in PTSD

Awaiting FDA Decision on MDMA-Assisted Therapy, with Bessel van der Kolk, MD

Apex Labs Submits FDA Application for Microdose Psilocybin Study

Apex Labs announced on June 20, 2024, the filing of an investigational new drug (IND) application with the FDA for APEX-52, a microdose, orally administered synthetic psilocybin to treat PTSD. Investigators plan on evaluating APEX-52 in a driving simulator study to assess when it would be safe for patients to drive following the medication.

“…The study aims to shed light on crucial driving data and understand the pharmacokinetics of psilocybin—specifically, how long it takes for active blood levels to become undetectable," said lead investigator Barbara C. Banz, PhD, from Yale School of Medicine, in a statement.

Successful Phase 3 Data

Lumateperone Significantly Enhances Antidepressant Effects in Phase 3 Trial

On June 18, 2024, Intra-Cellular Therapies announced the second phase 3 trial evaluating lumateperone 42 mg adjunctive therapy in patients with major depressive disorder (MDD) met its primary endpoint of change from baseline at week 6 on the Montgomery-Åsberg Depression Scale MADRS). Taking lumateperone daily alongside antidepressants brought a significant 4.5-point reduction on the MADRS total score (P < .0001), and improvement was seen as early as week 1 (P = .0504). The pivotal study also met its key secondary endpoint of change from baseline on the Clinical Global Impression Scale for Severity of Illness (P < .0001).