A wearable device, the RelivionDP system is designed as an adjunctive treatment to pharmaceutical management of major depressive disorder (MDD) in adults who have not achieved satisfactory improvement from antidepressant medications.
“Gaining FDA recognition of our potential to substantially impact an area of unmet need bolsters our upcoming RelivionDP Major Depression pivotal study, and brings us one step closer to reaching people who desperately need this new treatment,” said Chris Richardson, Neurolief’s Chairman. “This categorization is a major milestone for Neurolief, and we hope to one day make a significant difference for patients suffering from depression.”
Ninety percent of patients with major depressive disorder who had not sufficiently responded to previous pharmaceutical treatment showed improvement in depression rating when using RelivionDP, based on an open-label clinical study. In the same study, 37 percent of patients reached full remission from their depressive episodes. The study utilized the Hamilton Depression Rating Scale (HDRS).
“As we find ourselves in the midst of a large and growing global mental health crisis, more and more patients are in need of effective options that lack the short and long-term side effects we see with traditional treatments,” said Linda Carpenter, MD, a Professor of Psychiatry and Human Behavior in the Warren Alpert Medical School at Brown University. As per Dr. Carpenter, “Based on its efficacy and safety profile, RelivionDP could be the answer for the approximately 40 percent of patients with depression who do not respond to standard medication and psychotherapy treatments. The fact that it’s also wearable, allows for a personalized level of treatment, and has remote monitoring capabilities makes this an extremely attractive option for patients with major depression.”
The RelivionDP is a neurostimulation device similar to a simple headset that the patient places on their head to administer treatments in the comfort of their own home. It is designed to treat major depression by stimulating the release of neurotransmitters in the brainstem and modulating brain networks associated with control of mood. Utilizing three adaptive output channels, the device transfers mild electrical pulses to the brainstem via six branches of the occipital and trigeminal nerves which are responsible for sensation in the face, ears, and scalp. Part of a digital therapeutics platform, RelivionDP is used in tandem with its dedicated smartphone app and a cloud database to allow physicians to remotely monitor patients, analyze their data, and personalize treatments in ways which will enhance treatment outcomes.