May 01, 2026

Top News
FDA Approves First Non-Antipsychotic for Alzheimer’s Agitation: Auvelity Offers New Option
Diagnosis & Treatment
STAT+: Axsome wins FDA nod for Alzheimer’s agitation

The FDA has approved a new treatment for agitation associated with Alzheimer's disease, marking a significant development in managing behavioral symptoms of dementia.

Policy & Regulation
Study: During pandemic, dementia rose, antipsychotic use slipped among nursing home residents - McKnight's Long-Term Care News

A study indicates that while dementia prevalence increased among nursing home residents during the pandemic, antipsychotic prescribing rates decreased, highlighting a shift in prescribing patterns for this high-risk population.

Policy & Regulation
FDA approves Axsome's Auvelity for Alzheimer's agitation - qz.com

The FDA has approved Axsome's Auvelity (dextromethorphan/bupropion) for the treatment of agitation associated with Alzheimer's disease, providing a new pharmacologic option for this behavioral symptom.

Policy & Regulation
STAT+: Pharmalittle: We’re reading about obesity drugs and a compounding list, an AstraZeneca setback, and more

The FDA proposed excluding semaglutide and tirzepatide from the compounding list, a regulatory action with significant implications for the availability of GLP-1 obesity and diabetes treatments.

Policy & Regulation
Axsome wins first non-antipsychotic FDA approval for Alzheimer’s agitation - BioSpace

FDA granted approval to Axsome's first non-antipsychotic treatment for agitation associated with Alzheimer's disease, marking a significant shift in pharmacologic management for this behavioral symptom.

Clinical Pearls

Bite-sized clinical takeaways from today's literature (sources from Jan 16 – May 01)

  • Consider prescribing lumateperone for patients with schizophrenia who require maintenance therapy and may benefit from its distinct receptor binding profile to prevent relapse.
  • Evaluate Auvelity (dextromethorphan/bupropion) as a non-antipsychotic alternative for agitation in Alzheimer's disease to potentially avoid the black box warnings associated with antipsychotics in this population.
  • Monitor patients closely for signs of serotonin syndrome when prescribing Auvelity, given its dual mechanism involving dextromethorphan (NMDA antagonist/NRI) and bupropion (NDRI).
  • Utilize patient-selected music as a simple, low-cost adjunctive intervention to mitigate transient dissociative or ataxic side effects during intranasal esketamine treatment for treatment-resistant depression.
  • Be aware that the development of evenamide for treatment-resistant schizophrenia has been halted due to a patient death, indicating a significant safety concern for this investigational sodium channel blocker.
  • Consider the potential off-label repurposing of semaglutide for patients with comorbid alcohol use disorder and obesity, as recent data suggests it may reduce heavy drinking days.
  • Explore theta-burst transcranial magnetic stimulation as a non-pharmacologic option for improving social communication and language in autistic children with intellectual disability.
  • Exercise caution with sertraline prescriptions by verifying batch integrity and packaging, following recent recalls due to packaging mix-ups that risk unintended serotonergic side effects.
  • Recognize that combining cognitive behavioral therapy with psilocybin may offer rapid, significant, and sustained relief of major depression symptoms, supporting integrated treatment approaches.

Diagnosis & Treatment 4

MDMA-assisted therapy for depression: a promising but early first step

A small proof-of-principle trial suggests MDMA-assisted therapy may be feasible for depression, though the open-label design and pre-treated sample warrant caution.

Axsome's Auvelity is first non-antipsychotic cleared in US for Alzheimer's agitation - FirstWord Pharma

The FDA has approved Axsome's Auvelity (dextromethorphan/bupropion) as the first non-antipsychotic treatment for agitation associated with Alzheimer's disease, offering a new pharmacologic option for this indication.

Small dose of antibiotic yields good results in treating panic attacks

Preclinical and early human data suggest minocycline may be effective for panic disorder, showing effects comparable to clonazepam.

A five‑day course of magnetic brain stimulation could help autistic children communicate better

A randomized trial published in the BMJ demonstrates that a five-day course of theta-burst transcranial magnetic stimulation significantly improves social communication and language in autistic children with intellectual disability, offering a non-pharmacologic treatment option.

Policy & Regulation 1

FDA OKs First Non-Antipsychotic for Alzheimer’s Agitation - Medscape

The FDA has approved the first non-antipsychotic medication for treating agitation associated with Alzheimer's disease, offering a new prescribing option for this behavioral symptom.

Drug Development 5

MapLight Therapeutics Completes Enrollment in ZEPHYR Phase 2 Trial for Schizophrenia and Final Patient Visit in IRIS Phase 2 Trial for Autism Spectrum Disorder - Quiver Quantitative

MapLight Therapeutics has completed enrollment in two Phase 2 clinical trials evaluating its investigational compounds for schizophrenia and autism spectrum disorder.

Patient death prompts FDA pause on Newron’s Phase 3 schizophrenia study - BioSpace

The FDA has paused Newron's Phase 3 schizophrenia trial following a patient death, signaling a critical safety signal that may impact the development of this investigational antipsychotic.

Patient death puts Newron’s late-stage schizophrenia trial on ice - Clinical Trials Arena

A patient death has halted Newron's late-stage clinical trial for a schizophrenia treatment, representing a significant setback in the drug development pipeline for this indication.

Protocol for a systematic review and meta-analysis of the relationship between opioid exposure and dopaminergic measures in humans assessed by nuclear medicine imaging

This systematic review protocol aims to synthesize human neuroimaging data on dopaminergic dysregulation in opioid use disorder to identify mechanistic targets for novel pharmacotherapies beyond current mu-opioid receptor agonists.

Teva nabs experimental Tourette drug in $700M Emalex buyout

Teva acquired Emalex for $700M to advance its experimental drug for Tourette syndrome, signaling continued investment in neurologic and psychiatric therapeutic pipelines.

Substance Use 2

GLP-1 reduces heavy drinking days in treatment seeking people with alcohol use disorder and obesity, finds small trial

A small trial suggests semaglutide reduces heavy drinking days in patients with alcohol use disorder and obesity, highlighting a potential repurposing opportunity for GLP-1 agonists in substance use treatment.

‘If you've ever experienced it, you'd feel differently’: Exploring willingness and skepticism toward using higher dose naloxone products among people who use drugs in Maryland, United States

Qualitative study reveals that people who use drugs are willing to use higher dose naloxone for opioid overdoses but remain skeptical due to concerns about precipitated withdrawal and pharmaceutical marketing.

Clinical Pearl 3

Compulsive Polydipsia-Related Symptomatic Hyponatremia in a Low-Functioning Autistic Boy

This case report suggests low-dose mirtazapine as a viable pharmacologic alternative to SSRIs for treating compulsive polydipsia in autistic patients, avoiding the risk of SSRI-induced hyponatremia.

Rapid reduction of suicidal ideation with transient dissociative and “drunken gait” symptoms after intranasal esketamine, with music intervention: a case report

This case report describes the use of patient-selected music as an adjunctive intervention to mitigate transient dissociative and ataxic side effects during intranasal esketamine treatment for treatment-resistant depression, potentially improving tolerability and adherence.

Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia

A clinical trial is recruiting to evaluate the efficacy and safety of the dual orexin receptor antagonist daridorexant for treating insomnia in patients with major depressive disorder.

Mechanism of Action 2

Combinatorial effects of multi-site stimulation on depression-related brain regions: clinical data analysis and predictive modeling

This study analyzes intracranial neural activity in three treatment-resistant depression patients to characterize the network effects of combinatorial deep brain stimulation targets, providing mechanistic insights for optimizing surgical parameters.

Acute dose-dependent effects of 4-bromo-2,5-dimethoxyphenethylamine (2C-B) compared with 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin in a double-blind, placebo-controlled study in healthy participants - Nature

This study characterizes the acute dose-dependent effects of the psychedelic 2C-B relative to MDMA and psilocybin in healthy volunteers, providing mechanistic insights into psychedelic pharmacology relevant to future psychiatric therapeutic development.

Neuroscience 1

Beyond depression symptoms: the default mode network as a predictor of antidepressant response - Nature

This study identifies the default mode network as a potential neuroimaging biomarker for predicting antidepressant response, offering insights into the neural mechanisms underlying treatment efficacy in depression.

Digital Health 1

Intracranial Neural Biomarkers of Psychiatric Symptoms and Their Utility for Guiding Neuromodulation Therapy: A Systematic Review

This systematic review evaluates intracranial neural biomarkers to guide closed-loop neuromodulation therapies for treatment-resistant psychiatric disorders, highlighting the need to account for disorder-specific symptom time constants.