Remove Eating disorders Remove Pharmaceuticals Remove Sleep and mental health
article thumbnail

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

Psychiatric Times

SHOW MORE NRx Pharmaceuticals advances NRX-100, a preservative-free ketamine, through a fast-tracked FDA review for treating suicidal depression and PTSD. Sanom/Adobestock BREAKING NEWS A new formulation of ketamine is progressing through a novel US Food and Drug Administration review pathway, announced NRx Pharmaceuticals.

article thumbnail

The Psychiatric Pipeline in Review: Quarter 2, 2025

Psychiatric Times

The top 4 disease states this quarter were schizophrenia (41.7%), major depressive disorder (25%), and treatment-resistant depression (16.7%), and suicidal depression (16.7%). Trontinemab showed significant amyloid plaque reduction in Alzheimer's, validating Brainshuttle technology and prompting a phase 3 study.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

Psychiatric Times

The COMP005 trial is the first phase 3 study of synthetic psilocybin, marking a milestone in psychedelic research for mental health. No unexpected safety issues or imbalance in suicidal ideation were observed between treatment and placebo groups. points (95% CI [-5.7, -1.5]) in change at the primary endpoint.

article thumbnail

The 2025 Summer Heatwave: Implications for Patients With Psychiatric Disorders

Psychiatric Times

She has also served as advisory board participant for Supernus Pharmaceuticals and Axsome Therapeutics. Ms Barbee has a passion to reduce the stigma around mental health and promoting increased access to mental health care and education of both clinicians and the general public.

article thumbnail

Tardive Dyskinesia: Treat Functional Impairment, Not the AIMS Score

Psychiatric Times

of patients who were prescribed antipsychotics for their psychiatric illness and had evidence of tardive dyskinesia (TD) had TD recorded properly in their electronic health records, supporting the idea that TD is often underreported and misdiagnosed and, therefore, not treated appropriately.

article thumbnail

June in Review: Updates on the Psychiatric Treatment Pipeline

Psychiatric Times

NRx Pharmaceuticals seeks FDA approval for NRX-100, a preservative-free ketamine for suicidal depression and PTSD, via the National Priority Voucher pathway. Compass Pathways' COMP360 psilocybin has shown significant efficacy in a phase 3 trial for treatment-resistant depression, advancing psychedelic research in mental health.

article thumbnail

July in Review: Updates on the Psychiatric Treatment Pipeline

Psychiatric Times

Positive trial results for alixorexton and AD109 indicate promising treatments for narcolepsy and obstructive sleep apnea, respectively. TSND-201 received FDA Breakthrough Therapy designation for PTSD, demonstrating significant symptom reduction in the IMPACT-1 study. SHOW MORE Check out the pipeline updates from July!