Full Press Release Details
VistaGen Therapeutics Receives FDA Fast Track Designation for
Development of AV-101 as a Non-Opioid Treatment for Neuropathic
Designation highlights serious unmet need for new treatment options
for patients suffering from neuropathic pain
Second FDA Fast Track designation for AV-101 since December 2017
marks another milestone for VistaGen's R&D
SOUTH SAN FRANCISCO, Calif., October 3, 2018
VistaGen 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 AV-101 as a non-opioid, non-sedating treatment for
neuropathic pain. This is the second FDA Fast Track designation
granted to VistaGen since December 2017.
FDA's Fast Track designation is designed to facilitate the
development, and potentially expedite the review, of drugs to treat
serious or life-threatening conditions and fill an unmet medical
is an investigational, orally bioavailable, small molecule NMDA
(N-methyl-D-aspartate) receptor glycine B antagonist without
psychological or sedative side effects.
day in the U.S., more than 115 people
die from overdosing on opioids. We have
evaluated AV-101 in multiple models of serious CNS conditions,
including those that cause patients to suffer from neuropathic
pain, for which current treatment options are inadequate. After
considering peer-reviewed data published last year in The Journal
of Pain, together with published safety data from our Phase
1 program, we believe AV-101 has the potential to address the high
unmet need for a new non-opioid, non-sedating treatment for
neuropathic pain, said
Shawn Singh, Chief Executive Officer of VistaGen.
This important designation is especially timely given the
FDA's forceful commitment to address our nation's
opioid epidemic. The FDA's Fast Track designation for
development of AV-101 for neuropathic pain, together with the
previously granted Fast Track designation for major depressive
disorder, will allow our team to work closely with the FDA to bring
AV-101 to patients affected by two of our country's most
debilitating and widespread healthcare concerns as soon as
receipt of the FDA's Fast Track designation for the
development of AV-101 for neuropathic pain comes on the heels of
the recent official statement made by FDA Commissioner Scott
Gottlieb, stating that
plans to issue guidance documents to assist sponsors with
the development of new non-opioid pain medications, such as AV-101,
as therapeutic alternatives to the use of opioids. More
specifically, over the next 6 to 12 months, the FDA has stated it
anticipates issuing several documents intended to stimulate the
development of medications for specific types of pain, resulting in
smaller clinical trials, faster approvals and quicker launches of
About Neuropathic Pain
pain (NP) affects approximately 33 million people in the United
States (excluding patients with back pain).2 It is characterized by a steady burning
or "pins and needles" or "electric shock" sensation that results in
abnormal neuronal function after trauma to the nerve, viral
infections, certain medications, or metabolic insults.
is an investigational, orally bioavailable, small molecule NMDA
(N-methyl-D-aspartate) receptor glycine B antagonist without
psychological or sedative side effects. AV-101 has potential to be
a new at-home treatment for multiple CNS indications with high
unmet need. AV-101 is currently in Phase 2 clinical development in
the United States for major depressive disorder (MDD). ELEVATE
VistaGen's ongoing Phase 2 clinical trial designed to
evaluate the efficacy and safety of adjunctive use of AV-101 for
MDD in individuals with an inadequate response to standard
antidepressant therapy with either an FDA-approved SSRI or SNRI.
The FDA has granted Fast Track
designation for development of AV-101 as a potential
treatment of MDD and neuropathic pain.
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing new generation medicines for multiple CNS diseases and
disorders with high unmet need. For more information, please visit
and connect with VistaGen on Twitter,
Forward-Looking Statements
This release contains various statements concerning VistaGen's
future expectations, plans and prospects, including without
limitation, our expectations regarding development of AV-101 and
the potential of AV-101 for the treatment of MDD, NP and various
other CNS diseases and disorders constitute forward-looking
statements for the purposes of the safe harbor provisions under the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements are neither promises nor guarantees of
future performance and are subject to a variety of risks and
uncertainties, many of which are beyond our control, and may cause
actual results to differ materially from those contemplated in
these forward-looking statements. Among these risks is the
possibility that (i) we may encounter unexpected adverse events in
patients in our ELEVATE study or other clinical studies that cause
us to discontinue further development of AV-101, (ii) we may not be
able to successfully demonstrate the safety and efficacy of AV-101
at each stage of clinical development, (iii) success in preclinical
studies or in early-stage clinical trials may not be repeated or
observed in ongoing or future AV-101 studies, and ongoing or future
preclinical and clinical results may not support further
development of AV-101 or be sufficient to gain regulatory approval
to market AV-101, (iv) decisions or actions of regulatory agencies
may negatively affect the initiation or progress of ongoing or
future AV-101 clinical trials, and our ability to proceed with
further clinical studies or to obtain marketing approval, (v) we