This roundup highlights a number of FDA actions in June related to therapeutics for psychiatric illness. For information on approvals in other specialties during the first quarter of 2026, see our FDA Drug Approvals page.

Attention-Deficit/Hyperactivity Disorder (ADHD) Drug Approval Declined

The FDA declined to approve an investigational drug for the treatment of ADHD, citing manufacturing concerns in its complete response letter. The therapy, CTx-1301, has been shown to improve symptoms of ADHD among children and adolescents in clinical trials. There were no issues identified regarding the clinical safety or efficacy, manufacturer Cingulate said in a statement. 

Neuromodulation Device Cleared for Posttraumatic Stress Disorder (PTSD)

The FDA cleared the first biomarker-guided neuromodulation device for the treatment of PTSD in adults. The Magnetic EEG-guided Resonance Therapy — known as MeRT — uses rapid EEG assessments that analyze brain function to guide personalized transcranial magnetic stimulation treatment. The device was cleared based on trial results that showed clinically meaningful reductions in PTSD symptom severity, manufacturer Wave Neuroscience reported.

Increased Access for Opioid Overdose Nasal Spray

An over-the-counter naloxone nasal spray has received approval for the emergency treatment of opioid overdose. Rextovy delivers 4 mg of naloxone hydrochloride intranasally to reverse the effects of overdose and restore normal breathing. The approval will expand access to overdose medications for the public and is part of a federal initiative to address substance use disorder, FDA officials said in a statement.

Delays for Smoking Cessation Drug

The FDA declined approval of the investigational drug cytisinicline for smoking cessation, citing manufacturing-related issues and a delay in final product labeling in its complete response letter. Previous clinical trial data showed that the drug is associated with improved smoking abstinence rates compared to placebo. The decision was not based on the drug’s efficacy or safety, and the company plans to resubmit its application later this year, manufacturer Achieve Life Sciences said in a statement.

Expanded Access Protocol for Depression

Patients with treatment-resistant depression can now access an experimental drug under compassionate care grounds, based on an expanded access protocol issued by the FDA. NRX-101 (NRx Pharmaceuticals) is a fixed-dose combination of D-cycloserine and lurasidone for the augmentation of accelerated transcranial magnetic stimulation. The company plans to make NRX-101 available to physicians and patients while pivotal clinical trials are underway.