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5 Psychiatry Headlines You Missed in September 2025
This month in review focuses on innovative therapies in psychiatry, including MM120 for anxiety and ammoxetine for depression, as well as providing safety insights.
As September 2025 draws to a close, psychiatry research is pushing the field into new territory with innovative therapies and fresh safety insights. A phase 2b trial of MM120 (LSD) showed a single dose could deliver rapid and lasting relief for generalized anxiety disorder, while ammoxetine emerged as a promising antidepressant with fewer adverse events than current standards.
Meanwhile, the US Food & Drug Administration’s (FDA) release of Lykos Therapeutics’ CRL for MDMA-assisted therapy revealed key concerns shaping the future of psychedelic medicine. This psychiatry month in review highlights the top 5 news stories advancing treatment and reshaping debates in mental health care.
APhA, Autism Experts Dispute FDA’s Acetaminophen-Autism Link
FDA Initiates Acetaminophen Label Change, Leucovorin Approval for Cerebral Folate
The FDA has initiated a label change for acetaminophen to reflect evidence linking prenatal use with increased risks of autism and ADHD, though a causal relationship has not been established. Acetaminophen remains the only over-the-counter fever treatment considered safe in pregnancy, despite these concerns.
At the same time, the FDA has moved to approve leucovorin calcium (Wellcovorin) for cerebral folate deficiency (CFD), a rare condition associated with developmental delays, seizures, and autistic features. This decision follows a systematic review of literature and case reports supporting its benefit. The initiative highlights the FDA’s focus on repurposing older drugs for chronic conditions.
Related:
APhA and autism scientists dispute the FDA’s acetaminophen-autism link, citing rigorous studies showing no causal association and defending safe pregnancy use.
ACOG and AAP reject the FDA’s acetaminophen-autism label change, stressing lack of credible evidence and emphasizing its essential role in pregnancy care.
Prenatal Opioid Pain Medications Likely Not Linked to Autism or ADHD Risk
A large study found no causal link between prenatal prescribed opioid analgesic (POA) exposure and autism spectrum disorder (ASD) or ADHD in children. While unadjusted models suggested elevated risk, sibling comparisons and alternative analyses showed no significant associations, indicating confounding factors likely explain observed links.
FDA Releases CRL for MDMA-Assisted PTSD Therapy to the Public
FDA Releases CRL Detailing Safety Concerns for MDMA-Assisted Therapy in PTSD
The FDA publicly released Lykos Therapeutics’ Complete Response Letter (CRL) on MDMA for PTSD, citing safety and trial concerns. The agency highlighted 3 key issues: inadequate reporting of abuse-related or “positive” adverse events, lack of data on long-term durability beyond 18 weeks, and potential selection bias from participants with prior MDMA experience.
Additional recommendations included stronger safety monitoring, improved diversity, evaluation of psychotherapy’s contribution, and further pharmacokinetic and maternal health studies. While the CRL outlined 8 safety updates and 9 trial suggestions, the FDA emphasized these do not prevent approvability. Lykos stated it will continue negotiations with the agency.
Phase 2 MDD Research: MM120 for GAD, Ammoxetine for MDD
Single Dose of MM120 (LSD) Shows Lasting Anxiety Reduction in GAD: Phase 2b Results
A phase 2b randomized trial published in JAMA found a single 100 μg dose of MM120 (LSD) significantly reduced symptoms of generalized anxiety disorder (GAD), with effects sustained through 12 weeks. The trial included 198 adults with moderate to severe GAD and demonstrated a clear dose-response relationship, identifying 100 μg as the optimal dose.
At week 4, participants on 100 μg had a 65% response rate and 48% remission rate, with improvements maintained at week 12. The treatment was well tolerated, with transient perceptual changes and mild adverse events. These findings support the ongoing phase 3 development of MM120.
Daily Ammoxetine at 40, 60 mg Outperforms Placebo for MDD in Phase 2 Trial
A phase 2 randomized trial found daily ammoxetine at 40 mg and 60 mg significantly outperformed placebo in reducing depression severity, as measured by MADRS scores, in adults with major depressive disorder (MDD). Both doses showed efficacy comparable to existing antidepressants, while demonstrating fewer adverse events and a lower discontinuation rate than typically reported with SSRIs and SNRIs. No discontinuations occurred due to sexual dysfunction or liver issues, which are common concerns with other agents. Most adverse events were mild to moderate.
