The FDA has approved its first at-home, nondrug therapy for depression, a wearable brain stimulation headset developed by Flow Neuroscience.
The agency issued a green light that covers the device’s use both as a standalone treatment and in combination with other medications and that includes adults with moderate to severe major depressive disorder.
The prescription headset, dubbed FL-100, employs transcranial direct current stimulation to deliver a gentle electric current to the brain’s prefrontal cortex, the area that helps regulate a person’s mood and responses to stress. According to Flow, it’s a region that is often underactive in people with depression, which includes more than 20 million adults in the U.S.
The company said about a third of that population does not see success with antidepressants and that many still stop taking them due to certain side effects.
“Flow’s FDA approval is a watershed moment for the treatment of depression: the first step in moving from pharmaceutical treatments to tech-based therapies with minimal side effects,” Flow CEO Erin Lee said in a statement.
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In a randomized, sham-controlled clinical trial of 174 people that was published late last year in Nature Medicine, Flow’s approach delivered significant gains in clinician-led depression rating scales as well as self-reported questionnaires, following 10 weeks of at-home therapy sessions.
The device was worn for half an hour at a time while sitting or lying down, starting five times per week for the first three weeks before dropping to three sessions per week for the remainder of the study, which also included real-time remote supervision with video conferencing.
According to researchers, efficacy was seen in participants who were taking antidepressant medications related to treatment-resistant depression or undergoing psychotherapy as well as those who were not taking any medications.
“Among our real-world users, 77% see improvements in as little as three weeks,” said Kultar Garcha, M.D., Flow’s chief medical officer. “Such treatment, previously confined to clinics, can now be delivered at home, pointing to a scalable way of expanding access to effective depression care.”
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Sweden-based Flow Neuroscience previously launched its headset in the U.K. in 2019, pairing it with a behavioral therapy app, including videos and advice about depression and methods for managing symptoms through sleep, nutrition, fitness and meditation.
The company said its headset has been used by more than 55,000 people across the EU, the U.K.’s National Health Service, Switzerland and Hong Kong. It previously received a breakthrough designation from the FDA and more recently claimed a regulatory green light in Australia.
“For more than six years since the device’s launch in Europe, we’ve been building an evidence base globally with clinical trials, peer-reviewed research and real-world case reports. The approval of FL-100 in the U.S. will now offer millions of patients an accessible and effective non-drug treatment option,” said Daniel Månsson, Flow’s co-founder and chief scientific officer.
Flow said it aims to make the headset commercially available in the U.S. in the second quarter of next year and plans to study its use as a platform for traumatic brain injury, addiction and sleep disorders.
“We are committed to ensuring that Flow becomes a part of a standard treatment pathway for depression care,” Lee said. “We are singularly focused on helping as many patients as possible achieve remission from depression.”
