Due to favorable results of the interim analysis, the study will be completed as planned and submitted to the FDA and CE.
TAMPA, Fla., July 18, 2023 /PRNewswire/ — Neurolief, a medical neurotechnology innovator focused on neurological and neuropsychiatric disorders, today announced positive results from a planned interim analysis of the ongoing randomized controlled MOOD pivotal trial. MOOD is studying Relivion®DP, a new novel neuromodulation therapy for treatment of Major Depressive Disorder (MDD).
At a meeting of the study’s independent Data Monitoring Committee (DMC), statistical results from a pre-planned efficacy and safety interim analysis were reviewed. Based on data from 80% of the originally planned study sample size, the DMC issued a recommendation to continue patient enrollment up to the final planned sample size, as the interim results are “positively favorable”. Full study results will be announced and submitted to the FDA and CE after the last patient completes the treatment protocol, expected in the 2nd quarter of 2024.
“The successful results of this planned interim analysis are an extremely important milestone for our company,” stated Scott Drees, Chief Executive Officer of Neurolief. “MDD is a debilitating condition of epidemic proportion with severe negative impact on patients and humanity. Making this new promising therapy available is a top priority for Neurolief. It has the potential to be life-changing for treatment resistant depression (TRD) patients whose symptoms do not sufficiently improve with antidepressant medications. We can now progress toward making Relivion®DP available to the millions of patients in desperate need.”
The Relivion®DP is a neuromodulation system designed for treatment of depression and was awarded the FDA’s Breakthrough Device Designation for its novel technology. Similar to a headset, the patient places the device on their head to administer treatments. Utilizing three adaptive output channels, the device transfers mild electrical pulses to the brainstem via six branches of the occipital and trigeminal nerves. This mechanism stimulates the release of neurotransmitters in the brainstem and modulates brain networks associated with mood. Part of a digital therapeutics platform, Relivion®DP uses a dedicated smartphone app and a cloud database to allow psychiatrists to remotely monitor patients, analyze their data, and personalize treatments to enhance outcomes.
The MOOD clinical trial, conducted in 12 clinical sites across the US and 1 in Israel, is a prospective, multi-center, placebo controlled, randomized double-blind clinical trial. The study’s primary endpoint assesses changes in depression symptoms from baseline to 8 weeks post-treatment initiation when using Relivion®DP compared to the control group, in patients suffering from Major Depressive Disorder who failed to achieve satisfactory improvement from previous antidepressant medications.
About Major Depressive Disorder (MDD)
Depression is a leading contributor to disability worldwide.1 Major Depressive Disorder (MDD) is a common yet serious mood disorder in which people experience depressive symptoms that impair their social, occupational, or other important functioning such as depressed mood, loss of interest or pleasure in daily activities and suicidal tendencies. MDD affects more than 21 million US adults, or about 8.4% of the US adult population, in a given year.2 In 2018, the incremental economic burden of MDD was an estimated $326 billion in the US alone.3
About Neurolief
Neurolief is a neuromodulation company dedicated to improving the lives of patients suffering from Neurological and Neuropsychiatric disorders. The company is made up of highly experienced professionals with a proven track record in neuroscience, neuromodulation technology and the neurotech devices industry. The company has developed the Relivion®MG for treatment of migraine and the Relivion®DP for treatment of Major Depressive Disorder (MDD), which are the world’s first non-invasive multi-channel neuromodulation technologies designed to concurrently stimulate the occipital and trigeminal nerve branches in the head and thereby modulate brain networks associated with migraine and depression. Currently FDA and CE approved for the acute treatment of migraine, Relivion®MG is intended to provide a highly effective alternative to pharmaceutical therapies. It also incorporates a patient mobile app and clinical software with cloud enabled data-tracking feature sets, enabling next generation AI incorporation. The company is currently pursuing FDA and CE mark approvals for migraine prevention and for treatment of MDD.
For additional information on Neurolief and Relivion®, please visit the company’s website at www.relivion.com.
References:
1NIH-National Institute of Mental Health. Major Depression 2022.
2Anxiety & Depression Association of America. Depression Facts & Statistics.
3Greenberg PE, Fournier AA, Sisitsky T, et al. The economic burden of adults with major depressive disorder in the United States (2010 and 2018). Pharmacoeconomics. 2021;39(6):653-665.
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