Vistagen to Present Fasedienol (PH94B) Safety and Exploratory Efficacy Data from Phase 3 Open-Label Social Anxiety Disorder Study at American Society for Clinical Psychopharmacology Annual Meeting
30 Maio 2023 - 5:15PM
Business Wire
Late-breaking poster presentation highlights long-term,
open-label treatment data of as-needed intranasal administrations
of fasedienol in real-world setting
Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical
company aiming to transform the treatment landscape for individuals
living with anxiety, depression and other central nervous system
(CNS) disorders, today announced that safety and exploratory
efficacy data from its Phase 3 open-label study of fasedienol
(PH94B) nasal spray for the treatment of adults with social anxiety
disorder (SAD) will be presented in a late-breaking poster
presentation at the American Society for Clinical
Psychopharmacology (ASCP) 2023 Annual Meeting taking place in Miami
from May 30 through June 2, 2023.
Poster Session I: Wednesday, May 31, 2023, 11:15 a.m. to 1:00
p.m. Eastern Time Title: A Phase 3 Open-label Safety Trial of
Fasedienol (PH94B) Nasal Spray in the Treatment of Anxiety in
Adults With Social Anxiety Disorder (SAD) Poster Number: W74
The poster will be available at
https://www.vistagen.com/publication after the conclusion of the
conference.
About Fasedienol (PH94B)
Vistagen’s fasedienol (PH94B) is a first-in-class, rapid-onset
investigational pherine nasal spray with a novel proposed mechanism
of action (MOA) that regulates the olfactory-amygdala neural
circuits of fear and anxiety and attenuates the tone of the
sympathetic autonomic nervous system, without systemic
distribution, potentiation of GABA-A receptors or direct activity
on neurons in the brain. Vistagen is developing fasedienol in a
Phase 3 program for the treatment of social anxiety disorder.
Designed for intranasal administration in low microgram doses, the
proposed novel MOA of fasedienol is fundamentally differentiated
from all currently approved anti-anxiety medications, including all
antidepressants and benzodiazepines.
About Social Anxiety Disorder
Social anxiety disorder (SAD) affects an estimated 25 million
Americans. A person with SAD feels intense, persistent symptoms of
anxiety or fear in certain social situations, such as meeting new
people, making comments in a business meeting, dating, being on a
job interview, answering a question in class, or talking to a
cashier in a store. Doing common, everyday things in front of
people causes profound anxiety or fear of being embarrassed,
evaluated, humiliated, judged, or rejected. SAD can get in the way
of going to work, attending school, or doing a wide variety of
things in a situation that is likely to involve interpersonal
interaction. It can lead to avoidance and opportunity costs that
can significantly impact a person's employment and social
activities and can be very disruptive to their overall quality of
life. SAD is commonly treated long-term with certain FDA-approved
antidepressants, which have a slow onset of effect (several weeks)
and provide limited therapeutic benefits, and with benzodiazepines,
which are not FDA-approved for treating SAD. Both antidepressants
and benzodiazepines have known side effects and significant safety
concerns that may make them unattractive to individuals affected by
SAD.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders. Vistagen is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those that are currently available for
treatment of anxiety, depression and multiple CNS disorders.
Vistagen’s pipeline includes six clinical-stage product candidates,
including five investigational agents belonging to a new class of
drugs known as pherines, in addition to AV-101, an oral antagonist
of the glycine site of the N-methyl-D-aspartate receptor (NMDAR).
Pherines, which are administered as nasal sprays, are designed with
an innovative rapid-onset mechanism of action that activates
chemosensory neurons in the nasal passages and can selectively and
beneficially impact key neural circuits in the brain without
requiring systemic uptake or direct activity on CNS neurons.
Vistagen’s AV-101 inhibits activity of the ion channel of the NMDAR
but does not block it. Vistagen is passionate about transforming
mental health care and redefining what is possible in the treatment
of anxiety, depression and several other CNS disorders. Connect at
www.Vistagen.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230530005663/en/
Investors: Mark McPartland Senior Vice President, Investor
Relations (650) 577-3606 markmcp@vistagen.com
Media: Nate Hitchings SKDK nhitchings@skdknick.com
Vistagen Therapeutics (NASDAQ:VTGN)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Vistagen Therapeutics (NASDAQ:VTGN)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024