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sNDA Submitted: Lumateperone for the Prevention of Relapse in Schizophrenia

Psychiatric Times

An sNDA for Caplyta as an adjunctive treatment for adults with major depressive disorder (MDD) is also currently under FDA review, submitted back in December 2024. References 1. points (effect size 0.61) in study 501 and 4.5 points (effect size 0.56) vs placebo in study 502. Supplemental new drug application submitted to U.S.

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FDA Requires New Label Warning of Weight Loss Risk in Pediatric Patients Taking Extended-Release Stimulants for ADHD

Psychiatric Times

3 References 1. According to a national survey, an estimated 7 million (11.4%) US children aged 3-17 years have ever been diagnosed with ADHD and approximately half of children with ADHD (53.6%) received ADHD medication. FDA Drug Safety Communication. June 30, 2025.

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COMP360 Psilocybin for Treatment-Resistant Depression: Positive Phase 3 Efficacy Data

Psychiatric Times

References 1. After the FDA rejection of Lykos Therapeutics’ midomafetamine (MDMA)-assisted psychotherapy tempered excitement for psychedelic therapeutics, 2 this positive data could generate new momentum. News release. June 23, 2025.

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NRx Pharmaceuticals Applies for FDA National Priority Voucher for Intravenous Ketamine (NRX-100)

Psychiatric Times

References NRx Pharmaceuticals, Inc. The FDA has granted Fast Track Designation to NRX-100 for the treatment of acute suicidality, and NRx has also filed a patent application for its novel preservative-free formulation with the US Patent and Trademark Office. Press release. June 23, 2025.

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TSND-201 Receives Breakthrough Therapy Designation From FDA for PTSD

Psychiatric Times

References 1. 3 Unfortunately, approval at the time was not granted. Transcend Therapeutics Receives Breakthrough Therapy Designation for TSND-201 (methylone) for the Treatment of PTSD. Press release. Jul 10, 2025. Accessed July 10, 2025.

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Tardive Dyskinesia: Treat Functional Impairment, Not the AIMS Score

Psychiatric Times

References 1. Dr Miller is Medical Director, Brain Health, Exeter, New Hampshire; Editor in Chief, Psychiatric Times ; Staff Psychiatrist, Seacoast Mental Health Center, Exeter; Consulting Psychiatrist, Insight Meditation Society, Barre, Massachusetts. Griffiths K, Won Y, Lee Z, et al. BMC Psychiatry. 2025;25(1):407.

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How Do Psychiatry Residents Learn Psychopharmacology?

Psychiatric Times

References 1. Dr Stahl is an internationally recognized clinician, researcher and teacher in psychiatry with subspecialty expertise in psychopharmacology. He is currently a professor at the University of California, San Diego, and serves as Honorary Fellow in psychiatry department at the University of Cambridge. Stahl SM, Davis RL.

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