Subjects ” Neurological behavior disorders
The Food and Drug Administration (FDA) has granted BNC210 fast-track status for the acute treatment of social anxiety disorder (SAD) and other anxiety-related disorders.
BNC210 is an oral selective negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor. The designation is supported by data from a Phase 2a study investigating a single oral dose of BNC210 in patients with generalized anxiety disorder. The results showed that treatment with BNC210 significantly reduced threat avoidance behavior and connectivity between the amygdala and the anterior cingulate cortex.
The company will evaluate BNC210 in patients with SAD in the multicenter, randomized, double-blind, placebo-controlled phase 2 study PREVAIL, which is expected to begin in late 2021. Patients receive a single oral dose of BNC210 for approximately 1 hour prior to the behavioral task. The primary endpoint is self-reported anxiety levels using the scale of subjective units of distress during the behavioral task.
Continue reading
“There is no FDA-approved, fast-acting, on-demand treatment for SAD, and the current standard of care, FDA-approved antidepressants, and off-label use of benzodiazepines have significant potential side effects and safety concerns,” said Bionomics’ CEO Dr. Errol De Souza. “The new oral tablet formulation of BNC210, which is rapidly absorbed and reaches near maximum blood levels in approximately 1 hour, is being evaluated for the acute treatment of SAD patients to better cope with expected fear-inducing social interactions and other public attitudes.”
The FDA previously granted BNC210 fast-track status for the treatment of post-traumatic stress disorder (PTSD) and other trauma and stressor-related disorders.
relation
The US FDA grants BNC210 Bionomics Fast Track status for the acute treatment of social anxiety disorder and other anxiety-related disorders. Press release. Bionomics Limited. Accessed December 1, 2021. https://www.prnewswire.com/news-releases/us-fda-grants-bionomics-fast-track-designation-to-bnc210-for-the-acute-treatment-of-social – Anxiety-and-other-anxiety-related-disorders-301434695.html.
This article originally appeared on MPR
Subjects:
Anxiety Disorders Neurological Behavior Disorders
Would you like to read more?
Please log in or register first to view this content.
Login Register
Open minded
Next post in Neurobehavioral Disorders
Close
Close for more information on Negative Allosteric Modulator Receives Fast Track Status for Social Anxiety Disorder
Loading… 
Close for more information on Negative Allosteric Modulator Receives Fast Track Status for Social Anxiety Disorder
Loading…
Close for more information on Negative Allosteric Modulator Receives Fast Track Status for Social Anxiety Disorder
Loading…
Close for more information on Negative Allosteric Modulator Receives Fast Track Status for Social Anxiety Disorder
Loading…
Would you like to see more content from Neurology Advisor?
Register now for free to access unlimited clinical news with personalized daily tips for you, Full-length features, case studies, conference reports, and more.
{{login-button}} {{register-button}}
Would you like to read more?
Please log in or register first to view this content.
Login Register
