The TGA warned about the risk of homicidal ideation associated with atomoxetine in paediatric patients and published its February 2026 Product Information safety updates. The updates cover multiple medicines with changes to contraindications, warnings and adverse effects. Nearly one in five Australians took a prescription psychiatric drug in 2023-24.
NRx said the FDA issued a positive review letter on its preservative-free ketamine ANDA, requesting only minor administrative changes. The company also received FDA guidance outlining a path to an NDA for NRX-100 using clinical trial data and real-world evidence.
NRx Pharmaceuticals said an FDA Type C meeting indicated a path to an NDA for NRX-100, using clinical trial results and real-world ketamine data from more than 65,000 patients.
NRx said the FDA outlined a path for a New Drug Application for NRX-100, a preservative-free ketamine formulation for depression with suicidality. The company plans to submit the NDA by June 2026 and said no additional nonclinical or bridging studies would be required.
NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.
NRx Pharmaceuticals completed a Type C meeting with the FDA, receiving guidance to file a New Drug Application for NRX-100 based on existing trial data and real-world evidence from over 65,000 patients, with submission planned for Q2 2026.
NRx Pharmaceuticals completed a Type C meeting with FDA leadership and received oral guidance supporting a New Drug Application for NRX-100 (preservative-free ketamine) based on existing trial data and Real World Evidence from over 65,000 patients.
Compass Pathways announced positive results from its second Phase 3 trial of synthetic psilocybin COMP360 for treatment-resistant depression, showing a 3.8-point reduction in depression scores. The company plans to meet with the FDA to discuss a rolling approval application.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07745569 |
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies |
NOT_YET_RECRUITING | PHASE2 |
| NCT07420205 |
Sleep Health in U.S. Marines |
RECRUITING | PHASE2 |
| NCT07302295 |
Analysis of Suicidal Behavior Among Children and Adolescents in the Auvergne-Rhone-Alpes Region During the Covid 19 Pandemic Period |
RECRUITING | NA |
| NCT07256496 |
Enhanced Dialectical Behavior Therapy for Adolescents |
COMPLETED | NA |
| NCT06979479 |
Effectiveness of the Adapt for Life, Mental Wellness and Suicide Prevention Program |
ACTIVE_NOT_RECRUITING | |
| NCT06706232 |
Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality |
RECRUITING | PHASE2 |
| NCT06639477 |
Assessing Improvements in Mood and Sleep Trial |
RECRUITING | NA |
| NCT06636357 |
Nitrous Oxide in the Treatment of Acute Suicidal Ideation |
RECRUITING | PHASE2 |
| NCT06229132 |
Mental Health Support for Transgender and Gender-expansive Individuals |
COMPLETED | NA |
| NCT06073964 |
GBV, Primary Trauma & Trauma Resilience & Understanding Self-help Therapy Utilization in Uganda |
COMPLETED | NA |
