Psychiatry Month in Review: August 2024

Psychiatrists and patients alike anticipated the approval of midomafetamine (MDMA) capsules for the treatment of posttraumatic stress disorder (PTSD) that could forever alter the landscape of PTSD treatment and introduce psychedelics into the healthcare space.

All that came to a halt when the US Food and Drug Administration issued a complete response letter (CRL) for MDMA-assisted therapy for PTSD. This psychiatry month in review recaps HCPLive’s coverage of the fallout of the FDA’s decision on MDMA-assisted therapy, as well as other news in the psychiatry space.

The HCPLive psychiatry team highlights recently published studies on promising treatment options for schizophrenia and treatment-resistant depression, the finding that semaglutide is linked to suicidal ideation, and new mothers and prescribers’ experiences with zuranolone 1 year after FDA-approved zuranolone for postpartum depression.

FDA Issues a CRL for MDMA-Assisted Therapy for PTSD

FDA Rejects Application for MDMA-Assisted Therapy in PTSD, Calls for Additional Trial

The FDA issued a CRL letter for the treatment of MDMA-assisted therapy for PTSD, announced by Lykos Therapeutics on August 9, 2024. The decision followed negative feedback from the FDA’s Psychopharmacologic Drugs Advisory Committee who voiced concerns about the safety, cardiovascular risks, and issues related to functional unblinding in trial settings. The FDA requested that Lykos Therapeutics conduct an additional trial.

Related: Leading Experts Discuss FDA's Pending Decision on MDMA-Assisted Therapy for PTSD

PTSD Experts, Trial Participant Reacts to FDA’s Decision

Crisis Point: Psychiatry at a Crossroad Following FDA Decision on MDMA-Assisted Therapy

Following the FDA’s decision on MDMA-assisted therapy, HCPLive put together another episode of Crisis Point, a compilation of interviews of PTSD experts and a trial participant directly following the news. Everyone whom HCPLive spoke to had expressed their disappointment with this turn of events. Despite the decision, 1 of the PTSD experts, a former principal investigator for the phase 3 MAPS-sponsored MDMA-assisted therapy clinical trials from 2018 – 2023, remains optimistic that MDMA-assisted therapy will be a treatment option later down the road.

Related: MDMA-Assisted Therapy Trial Participant Reacts to FDA’s Decision on Lykos’ NDA

Zuranolone Experiences 1 Year After Its Approval

Zuranolone Offers New Hope for Treating Postpartum Depression in New Mothers

A year after the FDA approved zuranolone for postpartum depression on August 4, 2023, HCPLive spoke to a new mother who was one of the first to be prescribed this medication, as well as 2 prescribers. The medication has changed the patient’s life for the better, getting her out of her fog. Prescribers also shared their experiences treating their patients with zuranolone and how they take a personalized approach with each patient. Despite zuranolone’s availability, many patients are still unaware that the drug is out there.

Early Data Supporting Psychiatric Treatments

Phase 2 Data Supports the Effectiveness, Safety of NBI-1117568 for Schizophrenia

Phase 2 data supported the effectiveness of NBI-1117568 for schizophrenia. The once-daily 20 mg dose of NBI-1117568 provided a statistically significant 7.5-point improvement in the Positive and Negative Syndrome Scale (PANSS) Total Score compared to placebo at week 6 (P = .011) with an 18.2-point PANSS Total Score Improvement from baseline.

“We recognize the significant need for new and innovative medicines to treat schizophrenia and look forward to advancing NBI-'568, the first M4 selective agonist, into Phase 3 development early next year,” said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences, in a statement.

Phase 1b Trial Signals Benefit of VLS-01 for Treatment-Resistant Depression

Preliminary phase 1b results showed the potential benefit of VLS-01, a proprietary oral transmucosal film formulation of N,N-dimethyltryptamine (DMT) applied to the buccal surface, for treatment-resistant depression. Atai Life Sciences announced the positive data on August 13, 2024.

VLS-01 works by inducing a short psychedelic experience that typically resolves within 90 – 120 minutes. The treatment option was also well-tolerated, with adverse events either mild or moderate, and many resolved on the day of dosing. The most common treatment-emergent adverse events included headache, dissociation, euphoric mood, and nausea.

New Discoveries in the Psychiatry Space

Semaglutide Linked to Suicidal Ideation, New Study Reveals

A new study with sufficient power discovered semaglutide may be associated with increased suicidal ideation. Semaglutide, used to treat type 2 diabetes and chronic weight management, has a disproportionally increased reporting of suicidality. Thus, investigators sought to assess the link between semaglutide and suicidal ideation. Semaglutide-association suicidal ideation had significant disproportionality (Reporting odds ratio [ROR], 1.45; 95% confidence interval [CI], 1.18 – 1.77).