The first half of 2025 has brought several important US Food and Drug Administration (FDA) updates in psychiatry, ranging from new drug approvals and label expansions to promising trial data. These developments offer fresh treatment options and improved care strategies for conditions such as depression, schizophrenia, bipolar disorder, ADHD, and opioid use disorder (OUD).

2025 FDA Updates in Psychiatry

FDA Approvals: SUBLOCADE for OUD, Esketamine for TRD

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

Approval date: February 24, 2025

The FDA approved expanded use of the buprenorphine extended-release injection (SUBLOCADE) for OUD, allowing administration in the thigh, buttock, and upper arm in addition to the abdomen. The updated label also shortens induction from a 7-day lead-in to a single transmucosal dose with a 1-hour observation. These changes aim to improve flexibility, adherence, and outcomes for patients.

FDA Approves Label Update for Viloxazine Capsules to Include New Lactation Data

Approval date: January 27, 2025

The FDA approved a label update for viloxazine extended-release capsules (Quelbree) to include new lactation data, showing low transfer into breastmilk. The update also details viloxazine’s serotonin 5-HT2C receptor activity and norepinephrine transporter inhibition, expanding understanding of its pharmacodynamics.

Approved for ADHD in children and adults, viloxazine may increase blood pressure, heart rate, or cause manic episodes. The label update follows a study of 15 lactating women and supports more informed treatment decisions for breastfeeding patients managing ADHD with viloxazine.

FDA Approves Esketamine as First Monotherapy for Treatment-Resistant Depression

Approval date: January 21, 2025

The FDA approved esketamine (SPRAVATO) nasal spray as the first monotherapy for treatment-resistant depression (TRD) in adults. This approval follows a phase 4 trial showing rapid symptom improvement and superior MADRS score reductions at 4 weeks versus placebo. Esketamine previously required use alongside oral antidepressants, but can now be used alone, offering flexibility for patients who don’t respond to or tolerate oral treatments.

Additional FDA News in Psychiatry

PharmaTher Receives New Early June FDA Goal Date for Ketamine

PharmaTher received a new FDA goal date of June 4, 2025, for ketamine’s potential approval, covering anesthesia, pain, mental health, and neurological indications. The update followed an Amendment Acknowledgment Letter addressing minor manufacturing and microbiology issues from a prior complete response letter. No new clinical trials were requested.

PharmaTher aims to ease the longstanding ketamine shortage—on the FDA’s drug shortage list since 2018—that has contributed to the rise in unregulated compounded ketamine. If approved, PharmaTher could become a key supplier and help curb safety concerns tied to compounded use.

FDA Accepts sNDA for Risperidone Extended-Release Injectable Suspension for Bipolar I Disorder

The FDA has accepted the supplemental new drug application (sNDA) for UZEDY, a risperidone extended-release injectable, to treat adults with bipolar I disorder. Already approved for schizophrenia in 2023, UZEDY uses copolymer technology for sustained release. Teva and Medincell emphasized UZEDY’s potential to address nonadherence in bipolar care, though safety and efficacy for this new indication still need to be evaluated in clinical trials.

What’s Moving in the Psychiatry Pipeline

Compass Pathways’ COMP360 Psilocybin Shows Benefit in Phase 3 TRD Trial

Compass Pathways’ COMP360 psilocybin significantly reduced depression severity at 6 weeks in TRD patients during the phase 3 trial, with no new safety concerns.

Cobenfy Falls Short in Phase 3 ARISE Trial as Adjunctive Schizophrenia Therapy

Cobenfy (xanomeline-trospium) failed to show significant benefit over placebo as adjunctive schizophrenia therapy, though some subgroups showed promise.

Expert Insights: LB-102, Podcast Episodes on Ethics and SoCal Psych Previews

LB-102 Significantly Improves Disease Severity in Acute Schizophrenia, with John Kane, MD

LB-102 showed significant improvement in acute schizophrenia severity, reducing CGI-S and PANSS scores with good tolerability in a phase 2 trial.

The Gus Alva Perspective: SoCal Psych Preview—Schizophrenia Updates, with Jonathan Meyer, MD

At the SoCal Psychiatry Conference, Jonathan Meyer, MD, previewed xanomeline-trospium, a novel schizophrenia treatment improving symptoms with fewer adverse events.

The Gus Alva Perspective: SoCal Psych Preview—Tardive Dyskinesia, with Jonathan Meyer, MD

Jonathan Meyer previewed his SoCal Psychiatry session on tardive dyskinesia, emphasizing proactive management and its psychosocial impact.

The Gus Alva Perspective: SoCal Psych Preview—Metabolic Revolution in Mood Disorders, with Roger McIntyre, MD

Roger McIntyre previewed his keynote on targeting metabolic systems to treat and prevent mood disorders at the 2025 SoCal Psychiatry Conference.

Medical Ethics Unpacked: Shifting Vaccine Regulation and Policy, with Jason Schwartz, PhD

Jason Schwartz, PhD, discusses vaccine ethics, public trust, and COVID-19’s impact on immunization attitudes and policy challenges.

Medical Ethics Unpacked: Unique Ethical Challenges of Psychedelic Therapies

This episode explores ethical challenges of psychedelic therapies, including consent, access, cultural integration, dosing, and regulatory complexities.

Medical Ethics Unpacked: GLP-1 Allocation and Challenges of Equitable Access

This episode addresses GLP-1 drug allocation, which poses ethical challenges balancing fairness, access disparities, prioritization, adherence, and policies for obesity and diabetes treatment equity.