The year 2025 brought major advances in psychiatry, including US Food & Drug Administration (FDA) approvals of esketamine for treatment-resistant depression, expanded-use buprenorphine and risperidone injectables, and BrainsWay’s Deep TMS for adolescents with major depressive disorder (MDD), offering clinicians new tools for personalized, effective care.

Clinical trials highlighted promising therapies: TEV-‘749 for schizophrenia, centanafadine and solriamfetol for ADHD, and MM120 (LSD) for generalized anxiety disorder, alongside expert insights on dermatologic comorbidities, psychiatry research updates, and ethical considerations in psychedelic treatments, shaping the evolving psychiatric landscape.

FDA News

FDA Clears BrainsWay’s TMS Device for Adolescents with MDD Aged 15 to 21 Years

The FDA has cleared BrainsWay Ltd’s Deep TMS system for adolescents aged 15–21 years with MDD, announced on November 13, 2025. Supported by extensive real-world data, the noninvasive device delivers daily 20-minute sessions over 4–6 weeks, demonstrating significant reductions in depressive symptoms and comorbid anxiety.

FDA Approves Risperidone Extended-Release Injectable for Bipolar I Disorder

Announced on October 10, 2205, the FDA has approved Teva Pharmaceuticals’ UZEDY, a once-monthly, subcutaneous extended-release risperidone, for adults with bipolar I disorder. Using SteadyTeq™ technology, UZEDY provides controlled drug release, supporting maintenance therapy and addressing treatment gaps previously managed with oral or other long-acting formulations.

FDA Initiates Acetaminophen Label Change, Leucovorin Approval for Cerebral Folate Deficiency

The FDA has initiated a label change for acetaminophen, citing evidence linking prenatal use to increased autism and ADHD risk, while collaborating with GSK to approve leucovorin (Wellcovorin) for cerebral folate deficiency. Both actions aim to enhance awareness, improve safety, and expand treatment options for neurological conditions.

Related: APhA, Coalition of Autism Scientists Cite Insufficient Data to Support Acetaminophen, Autism Link

FDA Approves Expanded Use of Buprenorphine Extended-Release Injection for OUD Treatment

Announced on February 24, 2025, the FDA has approved expanded use of Indivior’s SUBLOCADE, a buprenorphine extended-release injection for opioid use disorder, adding thigh, buttock, and upper arm injection sites. Label updates reduce induction to a single dose with one-hour observation, improving adherence and supporting flexible, patient-centered treatment.

FDA Approves Esketamine as First Monotherapy for Treatment-Resistant Depression

The FDA has approved Johnson & Johnson’s esketamine (SPRAVATO®) nasal spray as the first monotherapy for adults with treatment-resistant depression, which was announced on January 21, 2025. Phase 4 trials demonstrated rapid, superior improvement in MADRS scores within 4 weeks, providing a standalone option for patients unresponsive to oral antidepressants.

Trial Updates

Teva Pharmaceuticals Submits NDA on TEV-‘749 for Schizophrenia to the FDA

Teva Pharmaceuticals submitted a New Drug Application (NDA) to the FDA for TEV-‘749, a once-monthly subcutaneous olanzapine extended-release injection for adult schizophrenia. Phase 3 SOLARIS trial data demonstrated efficacy, safety, and high patient, nurse, and physician satisfaction, offering a controlled-release alternative to oral olanzapine.

Otsuka Pharmaceuticals Submits NDA for Centanafadine to Treat ADHD in Children

Otsuka Pharmaceuticals submitted an NDA to the FDA for centanafadine, a novel NDSRI, for ADHD in patients aged 4–55 years. Four phase 3 trials showed significant, clinically meaningful improvements in ADHD symptoms with once-daily extended-release centanafadine, demonstrating a first-in-class mechanism and favorable tolerability.

J&J Submits sNDA to FDA for Lumateperone (CAPLYTA) to Prevent Schizophrenia Relapse

Johnson & Johnson submitted a supplemental NDA (sNDA) to the FDA for lumateperone (CAPLYTA) to prevent schizophrenia relapse. Phase 3 data showed a 63% reduction in relapse risk, characterized by high serotonin 5-HT2A receptor occupancy and lower dopamine D2 receptor occupancy, supporting its safety and long-term efficacy.

Solriamfetol Significantly Reduces ADHD Symptoms in Axsome’s Phase 3 Trial

Axsome Therapeutics’ FOCUS Phase 3 trial showed solriamfetol significantly reduced ADHD symptoms in adults, achieving a 45% mean reduction in AISRS scores versus placebo. Symptom improvement was observed as early as week 1, with a favorable safety and tolerability profile.

Single Dose of MM120 (LSD) Shows Lasting Anxiety Reduction in GAD: Phase 2b Results

A phase 2b trial by MindMed showed a single 100 μg dose of MM120 (LSD) significantly reduced anxiety in adults with GAD, with effects sustained through 12 weeks. Rapid improvements were seen by day 2, demonstrating dose-dependent efficacy and a favorable safety profile.

Related: Single Dose of MM120 Shows Rapid Anxiety Reduction in GAD, With Maurizio Fava, MD

Feature Content/Podcasts

Silent Weight of Psoriasis: Addressing Depression, Anxiety, Stigma in Care

Patients with psoriasis are 1.5 times likely to develop depression, highlighting the importance of routine mental health screening. Experts like Eva Parker, MD, of Vanderbilt Health, emphasize addressing both visible skin symptoms and the emotional impact to improve overall patient well-being.

Medical Ethics Unpacked: Unique Ethical Challenges of Psychedelic Therapies

In this episode of Medical Ethics Unpacked, hosts Steve Levine, MD, and Dominic Sisti, PhD, with guest Amy McGuire, JD, PhD, explore ethical challenges in psychedelic therapies, including consent, cultural integration, dosing, and clinical trial considerations.

Introducing The Gus Alva Perspective, with Gus Alva, MD

The Gus Alva Perspective, hosted by psychiatrist Gus Alva, MD, delivered biweekly expert insights on psychiatry, covering new treatments, research updates, and Southern California Psychiatry Meeting highlights to support clinicians in practice.