Axsome Therapeutics Receives FDA Fast Track Designation for AXS-05 for Alzheimer’s Disease Agitation
08 May 2017 - 9:00PM
Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, received Fast
Track designation from the U.S. Food and Drug Administration (FDA)
for AXS-05 for the treatment of agitation in patients with
Alzheimer’s disease (AD). There are currently no approved
treatments for this condition. Axsome previously received
Investigational New Drug Application (IND) clearance from the FDA
to proceed with a Phase 2/3 trial of AXS-05 in this indication.
“Agitation is reported in nearly half of
individuals living with Alzheimer’s disease, results in distress to
patients and caregivers, and has significant consequences including
early nursing home placement and increased mortality,” said Herriot
Tabuteau, M.D., Chief Executive Officer of Axsome. “The receipt of
Fast Track designation from the FDA highlights the serious nature
of this condition, the lack of FDA-approved treatments, and the
potential of AXS-05 to address this high unmet medical need.”
The FDA’s Fast Track designation program is
designed to aid in the development and expedite the review of drugs
that are intended to treat serious or life-threatening conditions.
In order to receive Fast Track designation, a product must also
demonstrate the potential to address an unmet medical need. Fast
Track designation provides greater access to, and more frequent
communication with, the FDA throughout the entire drug development
and review process, with the goal of getting important new drugs to
patients more rapidly. It also provides the opportunity to submit
sections of a New Drug Application (NDA) on a rolling basis, where
the FDA may review portions of the NDA as they are received instead
of waiting for the entire NDA submission. In addition, Fast Track
designated products are eligible for Priority Review at the time of
NDA submission.
About Alzheimer’s Disease (AD)
Agitation
Alzheimer’s disease (AD) is a progressive
neurodegenerative disorder that manifests initially as
forgetfulness advancing to severe cognitive impairment and memory
loss. It afflicts an estimated 5 million individuals in the United
States, a number that is anticipated to increase to approximately
14 million by 2050. In addition to cognitive decline, individuals
diagnosed with AD typically experience behavioral and psychological
symptoms including agitation which is reported in approximately 45%
of patients. Agitation is characterized by emotional distress,
aggressive behaviors, disruptive irritability, and disinhibition.
Agitation in patients with AD has been associated with increased
caregiver burden, decreased functioning, earlier nursing home
placement, and increased mortality. There are currently no
therapies approved by the FDA for the treatment of agitation in
patients with AD.
About AXS-05
AXS-05 is a novel, oral, investigational drug
product under development for the treatment of central nervous
system (CNS) disorders. AXS-05 utilizes Axsome’s technology of
combining bupropion and dextromethorphan. Dextromethorphan is an
NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor
of the serotonin and norepinephrine transporters. Bupropion serves
to increase the bioavailability of dextromethorphan, and is a
norepinephrine and dopamine reuptake inhibitor, and a nicotinic
acetylcholine receptor antagonist. AXS-05 is an investigational
drug product not approved by the FDA.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders for which
there are limited treatment options. Axsome’s product candidate
portfolio includes two late-stage candidates, AXS-05 and AXS-02.
AXS-05 is currently in a Phase 3 trial in treatment resistant
depression (TRD), and a Phase 2/3 trial in agitation in patients
with Alzheimer’s disease (AD) is planned. AXS-02 is currently in
Phase 3 trials in complex regional pain syndrome (CRPS) and knee
osteoarthritis (OA) associated with bone marrow lesions (BMLs) with
an additional Phase 3 trial planned in chronic low back pain (CLBP)
associated with Modic changes (MCs). AXS-05 and AXS-02 are
investigational drug products not approved by the FDA. For more
information, please visit the company website at www.axsome.com.
The company may occasionally disseminate material, nonpublic
information on the company website.
Forward Looking Statements
Certain matters discussed in this press release
are “forward-looking statements”. We may, in some cases, use terms
such as “predicts,” “believes,” “potential,” “continue,”
“estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,”
“could,” “might,” “will,” “should” or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. In particular, the Company’s statements
regarding trends and potential future results are examples of such
forward-looking statements. The forward-looking statements include
risks and uncertainties, including, but not limited to, the
completion, timing and proceeds of the public offering; the
success, timing and cost of our ongoing clinical trials and
anticipated clinical trials for our current product candidates,
including statements regarding the timing of initiation and
completion of the trials; the timing of and our ability to obtain
and maintain U.S. Food and Drug Administration or other regulatory
authority approval of, or other action with respect to, our product
candidates; the Company’s ability to successfully defend its
intellectual property or obtain the necessary licenses at a cost
acceptable to the Company, if at all; the successful implementation
of the Company’s research and development programs and
collaborations; the success of the Company’s license agreements;
the acceptance by the market of the Company’s product candidates,
if approved; and other factors, including general economic
conditions and regulatory developments, not within the Company’s
control. The factors discussed herein could cause actual results
and developments to be materially different from those expressed in
or implied by such statements. The forward-looking statements are
made only as of the date of this press release and the Company
undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstance.
Axsome Contact:
Mark Jacobson
Vice President, Operations
Axsome Therapeutics, Inc.
25 Broadway, 9th Floor
New York, NY 10004
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com
Axsome Therapeutics (NASDAQ:AXSM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Axsome Therapeutics (NASDAQ:AXSM)
Historical Stock Chart
From Apr 2023 to Apr 2024