The FDA has taken a string of actions in recent months that could reshape how substance use disorders, ADHD and other behavioral health conditions are treated in the years ahead.
From clearing a novel alcohol use disorder drug for trials to approaching the first new ADHD medication class in decades and backing psychedelic research under a White House directive, the agency’s recent moves point to accelerating momentum in behavioral health drug development.
Here are seven FDA actions to know:
1. The FDA granted Breakthrough Device Designation to the NET Device, made by Costa Mesa, Calif.-based NET Recovery, as an aid in reducing psychostimulant use in adults 18 and older diagnosed with stimulant use disorder.
The NET Device is a transcutaneous alternating current stimulator. It is currently cleared by the FDA for the management of opioid withdrawal symptoms in conjunction with standard symptomatic medications and other withdrawal therapies.
The Breakthrough Device Designation provides NET Recovery expedited FDA review and priority status for future submissions related to the stimulant use indication, though it does not change FDA clearance or approval requirements.
NET Recovery is designing a pivotal randomized controlled trial to support FDA marketing authorization. The company expects to pursue authorization through the De Novo pathway. The NET Device is not currently authorized for the treatment of stimulant use disorder, and that use remains investigational.
2. The agency cleared Hanover, N.H.-based Argus Cognitive’s Neurora, a software tool that analyzes behavioral data to assist clinicians in diagnosing autism in children ages 18 months through 12 years.
The tool analyzes video and audio recordings collected during standard behavioral assessments, measuring more than 100 vocal, facial and gaze biometrics. It then compares those measurements with behavioral patterns observed in children with and without an autism diagnosis.
Neurora is classified as a Class II pediatric autism spectrum disorder diagnosis aid and does not require clinicians to change their existing assessment protocols or use proprietary hardware. The results are intended to inform clinical decision-making rather than provide a standalone diagnosis.
3. The agency cleared Amygdala Neurosciences’ Investigational New Drug application for ANS-858, allowing the company to move the drug into clinical development.
ANS-858 is a selective, reversible, orally bioavailable inhibitor of aldehyde dehydrogenase 2 (ALDH2). It plans to begin a phase 1 clinical trial, which is designed to support later evaluation of ANS-858 across multiple indications in phase 2 clinical trials.
Amygdala Neurosciences is initially advancing ANS-858 as a potential treatment for alcohol use disorder and other substance use disorders. It is also evaluating the drug in compulsive eating disorders associated with binge eating and obesity.
The company is separately evaluating its selective ALDH2 inhibitors in precision oncology, including as a potential therapeutic approach for colorectal cancers harboring adenomatous polyposis coli (APC) mutations.
4. The FDA approved Simtriyo (centanafadine), making it the first and only approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older weighing at least 20 kilograms.
Simtriyo works by inhibiting the reuptake of norepinephrine, dopamine and serotonin, increasing the availability of these neurotransmitters in pathways involved in attention and behavioral regulation.
The approval was based on four pivotal phase 3 clinical trials in adults, adolescents and children. The studies showed statistically significant improvements in ADHD symptoms compared with placebo, with improvements observed as early as week one.
Otsuka said Simtriyo is expected to become available later this year after scheduling by the Drug Enforcement Administration.
5. The agency granted de novo approval to Modius Spero, marking it the world’s first neuromodulation device authorized to treat symptoms associated with post-traumatic stress disorder.
The wearable device was developed by Neurovalens and uses low-level electrical stimulation to target specific areas of the brain associated with PTSD symptoms, according to a May 26 news release from the company. The approval followed a U.S. clinical trial of 383 adults with clinical PTSD diagnoses.
The FDA’s de novo pathway is a risk-based classification process for novel medical devices that lack a legally marketed predicate.
In the study, participants received either the Modius Spero headset or an active sham device. Two-thirds of participants using Modius Spero reported a “clinically meaningful improvement in PTSD symptoms.”
The device is designed for adults ages 22 and older and delivers 30-minute daily sessions of noninvasive nerve stimulation prescribed and overseen by a healthcare professional as part of a broader treatment plan.
Neurovalens said Modius Spero will become available to veterans through the U.S. Department of Veterans Affairs “from this summer onwards.”
6. The FDA issued national priority vouchers to three companies studying psychedelic drugs to treat serious mental illness.
The vouchers were issued to companies studying psilocybin for treatment-resistant depression and major depressive disorder as well as methylone for post-traumatic stress disorder, following President Donald Trump’s April 18 executive order. The order directed federal agencies to accelerate research, regulatory review and access to psychedelic drugs, including ibogaine compounds, for serious mental illnesses.
The agency also allowed an early phase clinical study of noribogaine hydrochloride to proceed following an Investigational New Drug submission. The study will evaluate the compound as a potential treatment for alcohol use disorder, marking the first U.S. clinical study of a derivative of ibogaine.
The FDA said its decision to allow the study does not indicate the drug is approved or proved safe or effective, according to the release. The agency will continue reviewing data as it becomes available.
7. The FDA approved a new use for Wellcovorin, or leucovorin calcium tablets, to treat cerebral folate deficiency, after initiating efforts to expand approval for autism-related symptoms.
The approval marks the first FDA-approved treatment for the rare genetic disease, which affects the transport of folate — a vitamin essential for brain health — into the brain. The drug is also approved to treat chemotherapy side effects.
Patients with folate receptor 1 gene-related cerebral folate deficiency can experience developmental delays, movement disorders, seizures and other neurological complications.
Former FDA Commissioner Marty Makary, MD, said the treatment may benefit some individuals who have “developmental delays with autistic features.”
The agency refrained from approving the medication as a treatment for autism. In September, Mr. Trump and Dr. Makary shared intentions to expand the drug’s approved use to treat some autism symptoms.
A senior FDA official said the agency did not have sufficient data to “establish the efficacy for autism more broadly,” NBC News reported.
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