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Nobilis Therapeutics Announces FDA Clearance of IND to Commence Phase 2b Trial of NBTX-001 Inhaler for Treatment of Panic Disorder

PORTLAND, Ore., July 22, 2020 /PRNewswire-PRWeb/ --A Nobilis Therapeutics, a clinical stage biotechnology company focused on advancement of innovative CNS therapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for NBTX-001 Inhaler, allowing the Company to initiate its Phase 2b trial for the treatment of patients with Panic Disorder (PD)."We are very excited to receive FDA IND clearance for NBTX-001 drug-device combination," said Dr. Vlad Bogin, Company's Founder and CEO. "Being allowed to proceed with the study during the ongoing COVID-19 pandemic could not be timelier. Addition of PD indication to the already cleared phase 2b trial in patients with PTSD is giving Nobilis Therapeutic a unique opportunity to address the two most severe manifestations of the emerging worldwide mental health crisis," concluded Dr. Bogin. About NBTX-001NBTX-001 is a uniquely engineered drug-device combination specifically designed to provide a differentiated pharmaceutical therapy for the treatment of PTSD. Its proprietary portable inhalation device delivers a xenon gas mixture that has an exceptional safety profile proven by decades of clinical use in general anesthesia. Xenon is a competitive NMDA receptor antagonist devoid of dissociative and habit-forming properties which gives it distinct advantages over other agents in its class. It can be administered briefly in a safe and effective manner via a patent-pending portable inhalation device. In December of 2019 NBTX-001 was cleared for a phase 2b clinical trial in about 200 patients with PTSD. The trial will commence in around 20 U.S. sites with Harvard's McLean Hospital being the leading institution.About the PD clinical trial
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