Medication, Device, Digital Therapeutics Updates*

Rextovy (naloxone hydrochloride) – New OTC Approval June 2026

Rextovy, a 4mg naloxone hydrochloride nasal spray, is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, and not available to consumers without a prescription.

Modius Spero – New Device Approved May 2026

Modius Spero, a wearable, non-invasive neuromodulation device, received de novo approval to treat patients with “symptoms associated with post-traumatic stress disorder (PTSD).

Caplyta (lumateperone) – New Labeling April 2026

Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia, bipolar depression, and major depressive disorder, and has been approved for reduced risk of relapse on schizophrenia.

Bysanti (milsaperidone) – New Medication Approved February 2026

Bysanti (milsaperidone) is a new atypical antipsychotic for use in the treatment of schizophrenia and acute bipolar I disorder.

Naloxone HCI Nasal Spray 4 mg (Narcan) – New Packaging Approved February 2026

The United States Food and Drug Administration (US FDA) approved the (OTC naloxone HCl Nasal Spray 4 mg (Narcan) to be packaged in a new carrying case to improve ease of transport and usability.

Glucagon-Like Peptide-1 Receptor Agonist Medications – FDA Alert January 2026

FDA requested that drug application holders remove information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that currently include such language.

Practice Guidelines and Other Products

new! Training Slides for the Practice Guidelines on Borderline Personality Disorder and Delirium

Two new sets of training slides (.ppt) are available based on the APA Practice Guidelines on Borderline Personality Disorder and Delirium. The slides can be used by training directors or others teaching residents and fellows, as well as for grand rounds and other education opportunities.

Digital Health

Administrative Simplification Legislation Guidance (.pdf)

FAQs in response to the Final Rule requiring health care systems and providers to move away from faxing, mailing, or uploading documents separately and standardizing a way to send medical records electronically along with claims including required documentation like clinical notes or reports.

AI Prescribing Blog - Updated

This blog post covers Innovation, Risk, and the Need for Guardrails.

AI Scribe Tools - Updated

New response from Medwriter to questions on helping members assess AI scribe tools.

Telepsychiatry Blog - Updated

Information on telehealth flexibilities through December 2027.

Practice Management

new! Resource Document on Psychiatrists in a Supervisory Role (.pdf)

This guide gives a general overview of considerations psychiatrists may apply to their supervision of advanced practice providers.