Axsome Therapeutics Initiates FOCUS Phase 3 Trial of Solriamfetol for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults
07 7월 2023 - 8:00PM
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
announced that it has dosed the first patient in the FOCUS Phase 3
trial of solriamfetol, an investigational treatment for attention
deficit hyperactivity disorder (ADHD) in adults.
FOCUS (Forward Treatment of Attention Deficit
and Hyperactivity Using Solriamfetol) is a Phase 3, randomized,
double-blind, placebo-controlled, multicenter trial to assess the
efficacy and safety of solriamfetol for the treatment of ADHD in
adults. Approximately 450 patients will be randomized in a 1:1:1
ratio to receive solriamfetol (150 mg or 300 mg) or placebo for 6
weeks. The primary endpoint will be change in the Adult ADHD
Investigator Symptom Report Scale (AISRS).
About Attention Deficit Hyperactivity
Disorder (ADHD)
ADHD is a chronic neurobiological and
developmental disorder characterized by a persistent pattern of
inattention, hyperactivity or impulsivity, that interferes with
functioning or development.1 Impairments in cognition are apparent
in attention, planning and problem solving, working memory, and
behavioral inhibition.2,3 An estimated 11.4 million adults in the
U.S. are diagnosed with ADHD, and the condition affects an
estimated 5% of children and adolescents.4,5 Approximately
two-thirds or more of children with ADHD continue to have symptoms
and challenges in adulthood.6 The total annual societal excess
costs associated with adult ADHD in the U.S. have been estimated at
$122.8 billion.7
About Solriamfetol
Solriamfetol is a dopamine and norepinephrine
reuptake inhibitor. In vitro studies have also shown that
solriamfetol has agonist activity at trace amine-associated
receptor 1 (TAAR1) and 5HT1a receptors. Solriamfetol is not
approved by the FDA for the treatment of ADHD.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical
company developing and delivering novel therapies for central
nervous system (CNS) conditions that have limited treatment
options. Through development of therapeutic options with novel
mechanisms of action, we are transforming the approach to treating
CNS conditions. At Axsome, we are committed to developing products
that meaningfully improve the lives of patients and provide new
therapeutic options for physicians. For more information, please
visit the Company’s website at 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
continued commercial success of our Sunosi® and Auvelity® products
and the success of our efforts to obtain any additional
indication(s) with respect to solriamfetol and/or AXS-05; 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, pace of
enrollment and completion of the trials (including our ability to
fully fund our disclosed clinical trials, which assumes no material
changes to our currently projected revenues or expenses), futility
analyses and receipt of interim results, which are not necessarily
indicative of the final results of our ongoing clinical trials, and
the number or type of studies or nature of results necessary to
support the filing of a new drug application (“NDA”) for any of our
current product candidates; our ability to fund additional clinical
trials to continue the advancement of our product candidates; the
timing of and our ability to obtain and maintain U.S. Food and Drug
Administration (“FDA”) or other regulatory authority approval of,
or other action with respect to, our product candidates; whether
issues identified by FDA in the complete response letter may impact
the potential approvability of the Company’s NDA for AXS-07 for the
acute treatment of migraine in adults with or without aura,
pursuant to our special protocol assessment for the MOMENTUM
clinical trial; 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 products and product
candidates, if approved; the Company’s anticipated capital
requirements, including the amount of capital required for the
continued commercialization of Sunosi and Auvelity and for the
Company’s commercial launch of its other product candidates, if
approved, and the potential impact on the Company’s anticipated
cash runway; unforeseen circumstances or other disruptions to
normal business operations arising from or related to COVID-19; 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 Contacts: Investors:Mark JacobsonChief
Operating OfficerAxsome Therapeutics, Inc.One World Trade Center,
22nd FloorNew York, NY 10007Tel:
212-332-3243Email: mjacobson@axsome.comwww.axsome.com
Media:Darren OplandDirector, Corporate Communications Axsome
Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY
10007Tel: 929-837-1065Email: dopland@axsome.com
www.axsome.com
References:
- American
Psychiatric Association, Diagnostic and Statistical Manual of
Mental Disorders, 5 ed., Arlington, VA: American Psychiatric
Publishing, 2013.
- T. E. Brown,
"ADD/ADHD and impaired executive function in clinical practice,"
Current Psychiatry Reports, vol. 10, p. 407–411, 2008. doi.
10.1037/pne0000271
- E. Nestler, S.
Hyman and R. Malenka, Molecular Neuropharmacology: A Foundation for
Clinical Neuroscience, Second Edition, 2nd edition ed., New York:
McGraw-Hill Professional, 2008.
- Faraone, S.,
Asherson, P., Banaschewski, T. et al.
Attention-deficit/hyperactivity disorder. Nat Rev Dis Primers 1,
15020 (2015). https://doi.org/10.1038/nrdp.2015.20
- Kessler RC, et
al. The prevalence and correlates of adult ADHD in the United
States: results from the National Comorbidity Survey Replication.
Am J Psychiatry. 2006 Apr;163(4):716-23. doi:
10.1176/ajp.2006.163.4.716
- Sibley, MH et
al. Variable Patterns of Remission From ADHD in the Multimodal
Treatment Study of ADHD. Am J Psychiatry. 2022 Feb;179(2):142-151.
doi: 10.1176/appi.ajp.2021.21010032.
- Schein J, et al.
Economic burden of attention-deficit/hyperactivity disorder among
adults in the United States: a societal perspective. JMCP. 2022.
28:2, 168-179. doi: 10.18553/jmcp.2021.21290
Axsome Therapeutics (NASDAQ:AXSM)
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Axsome Therapeutics (NASDAQ:AXSM)
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