Full Press Release Details
U.S. FDA Grants VistaGen Therapeutics Fast Track Designation for
PH94B for Treatment of Social Anxiety Disorder
VistaGen's PH94B is the first drug candidate to be granted
U.S. FDA Fast Track designation
for treatment of social anxiety disorder
South San Francisco, Calif., (December 10, 2019)
Therapeutics, Inc. (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
central nervous system (CNS) diseases and disorders with high unmet
need, today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation for development of the
Company's PH94B neuroactive nasal spray for on-demand
treatment of social anxiety disorder (SAD).
FDA's Fast Track process is designed to facilitate the
development and review of new treatments for serious conditions
with unmet medical need, such as SAD, with the purpose of getting
innovative new treatment options to patients sooner. After
successful Phase 2 development, VistaGen is preparing PH94B for
Phase 3 development. PH94B has potential to be the first
fast-acting, non-sedating, as-needed treatment for as many as 20
million individuals in the U.S. suffering from SAD.
FDA's grant of Fast Track designation for development of
PH94B for SAD, which to our knowledge is the FDA's first Fast
Track designation for a SAD drug candidate, is another important
regulatory milestone for VistaGen and a key step forward in our
development program for PH94B as a new generation anxiolytic. With
a high global prevalence of anxiety disorders, including SAD, and
alarming increases in dependency, addiction and even deaths
associated with misuse of benzodiazepines, the urgency for a new
non-addictive, non-sedating, fast-acting, as-needed treatment for
SAD and other anxiety disorders is more important now than ever
before. Based on clinical studies to date, PH94B, at non-systemic
microgram doses, has strong potential to fill the large current
Shawn Singh, Chief Executive Officer of VistaGen.
Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for CNS diseases and disorders
where current treatments are inadequate, resulting in high unmet
need. VistaGen's pipeline is
focused on clinical-stage CNS drug candidates with differentiated
mechanisms of action, exceptional safety profiles in all clinical
studies to date, and therapeutic potential in multiple large and
growing CNS markets. For more information, please
visit www.vistagen.com and
connect with VistaGen on Twitter, LinkedIn and Facebook.
PH94B is a first-in-class, odorless, rapid-onset
(approximately 10 to 15 minutes) CNS neuroactive nasal spray with
the potential to be the first FDA-approved, fast-acting, on-demand
treatment for millions of Americans who suffer from social anxiety
disorder (SAD), with additional potential in peripartum anxiety,
pre/postoperative anxiety, post-traumatic stress disorder, panic
disorder and generalized anxiety disorder. Administered at
microgram doses, PH94B activates nasal chemosensory receptors that
trigger neural circuits in the brain that suppress fear and anxiety
associated with everyday social and work or performance situations.
Following successful Phase 2 development, VistaGen is preparing for
Phase 3 clinical development of PH94B for social anxiety disorder.
The FDA has granted Fast Track designation for development of PH94B
as a treatment for SAD. View
more background on SAD and PH94B's mechanism of
About Social Anxiety Disorder
anxiety disorder (SAD) affects as many as 20 million Americans and
is the second most commonly diagnosed anxiety disorder.1,2 A person with SAD
feels symptoms of extreme anxiety or fear in certain social
situations, such as meeting new people, dating, being on a job
interview, answering a question in class, or making small talk to a
cashier in a store or a networking event at work. Doing everyday
things in front of people - such as eating or drinking in front of
others or using a public restroom - also causes anxiety or fear.
The person is afraid that he or she will be humiliated, judged, and
rejected. SAD can significantly compromise academic, social and
work life and can predispose individuals to other anxiety
disorders, depression and substance use disorders.3 There is no
FDA-approved medication for as-needed, on-demand treatment of SAD.
While three antidepressants (two SSRIs and one SNRI) are
FDA-approved for treatment of SAD, they take many weeks to work, if
they work at all, must be taken chronically, and often present
troubling side effects. Individuals affected by SAD need novel
treatment alternatives with fast onset therapeutic benefits and far
About Fast Track Designation
Track is a process designed by the FDA to facilitate the
development, and expedite the review, of drugs to treat serious
conditions and fill an unmet medical need. Drugs that receive Fast
Track Designation may be eligible to be the subject of more
frequent communications and meetings with FDA to review the drug's
development plan including the design of the proposed clinical
trials, use of biomarkers and the extent of data needed for
approval. Drugs with Fast Track Designation may also qualify for a
priority, expedited FDA review process, if relevant criteria are
met. The purpose is to get important new drugs to the patient
earlier. Fast Track addresses a broad range of serious conditions.
For more information about Fast Track, please visit:
Forward-Looking Statements
This release contains various statements concerning VistaGen's
future expectations, plans and prospects, including without
limitation, our expectations regarding development and
commercialization of our three drug candidates: (i) PH94B for
social anxiety disorder and multiple other anxiety disorders; (ii)
PH10 for MDD and multiple additional depression disorders and
suicidal ideation, and (iii) AV-101 for MDD, neuropathic pain,