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 will host a virtual event on Tuesday, June 28,
2022 at 9:00 AM EDT to provide investors an update on Sunosi®
(solriamfetol). Sunosi is the first and only dual-acting dopamine
and norepinephrine reuptake inhibitor (DNRI) indicated to improve
wakefulness in adult patients with excessive daytime sleepiness
(EDS) due to narcolepsy or obstructive sleep apnea (OSA).
The event will include clinical overviews of
current and potential future indications provided by invited
physician experts. The Axsome senior management team will also
provide an overview of Sunosi commercial activities and clinical
development plans. The presenters will be available to answer
questions at the end of the presentations. To access the event
please click here.
The live webcast may be accessed on the
"Webcasts & Presentations" page of the "Investors" section of
the Axsome website at axsome.com. A replay of the webcast will be
available for approximately 30 days following the live event.
About Sunosi®
(solriamfetol)
Sunosi is a dual-acting dopamine and
norepinephrine reuptake inhibitor shown to improve wakefulness in
adults living with excessive daytime sleepiness (EDS) due to
narcolepsy or obstructive sleep apnea (OSA). Sunosi received U.S.
Food and Drug Administration approval on March 20, 2019 to improve
wakefulness in adult patients with EDS associated with narcolepsy
or OSA and was designated a Schedule IV medicine by the U.S. Drug
Enforcement Agency on June 17, 2019. SK Biopharmaceuticals Co.,
Ltd., the discoverer of the compound, maintains rights in 12 Asian
markets, including Korea, China and Japan. Sunosi has orphan drug
designation for narcolepsy in the United States.
More information about Sunosi, including
Full Prescribing Information and Medication Guide, is
available here.
Important Safety
Information
SUNOSI (solriamfetol) is available in 75
mg and 150 mg tablets and is a federally controlled substance (CIV)
because it contains solriamfetol that can be a target for people
who abuse prescription medicines or street drugs. Keep
SUNOSI in a safe place to protect it from theft. Never give or sell
your SUNOSI to anyone else because it may cause death or harm them
and it is against the law. Tell your doctor if you have ever abused
or been dependent on alcohol, prescription medicines, or street
drugs.
Before taking SUNOSI, tell your doctor
about all of your medical conditions, including if
you:
- have heart problems, high blood
pressure, kidney problems, diabetes, or high cholesterol.
- have had a heart attack or a
stroke.
- have a history of mental health
problems (including psychosis and bipolar disorders), or of drug or
alcohol abuse or addiction.
- are pregnant or planning to become
pregnant. It is not known if SUNOSI will harm your unborn
baby.
- are
breastfeeding or plan to breastfeed. It is not known if SUNOSI
passes into your breast milk. Talk to your doctor about the best
way to feed your baby if you take SUNOSI.
What are the possible side effects of
SUNOSI?
SUNOSI may cause serious side effects,
including:
- Increased blood pressure and heart rate.
SUNOSI can cause blood pressure and heart rate increases that can
increase the risk of heart attack, stroke, heart failure, and
death. Your doctor should check your blood pressure before, and
during, treatment with SUNOSI. Your doctor may decrease your dose
or tell you to stop taking SUNOSI if you develop high blood
pressure that does not go away during treatment with SUNOSI.
- Mental (psychiatric) symptoms including anxiety,
problems sleeping (insomnia), irritability, and agitation.
Tell your doctor if you develop any of these symptoms. Your doctor
may change your dose or tell you to stop taking SUNOSI if you
develop side effects during treatment with SUNOSI.
The most common side effects of SUNOSI
include:
- headache
- decreased appetite
- problems sleeping
- nausea
- anxiety
These are not all the possible side effects of
SUNOSI. Call your doctor for advice about side effects.
You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please find full Prescribing Information here:
https://sunosihcp.com/assets/files/sunosi-pi.pdf
SUN CON ISI 05/2022
About Obstructive Sleep Apnea and
Excessive Daytime Sleepiness
Obstructive sleep apnea, commonly referred to as
sleep apnea, is a highly prevalent disease (as high as 14% in men
and 5% in women) in which excessive daytime sleepiness is a major
presenting complaint in many cases. Positive Airway Pressure (PAP)
therapy, with its most common form being Continuous Positive Airway
Pressure (CPAP), has been shown to be an effective therapy for
sleep apnea that frequently results in improvement in excessive
daytime sleepiness in many patients; however, not all patients
tolerate CPAP therapy and among those who tolerate CPAP, usage is
highly variable. Excessive daytime sleepiness may persist in people
with sleep apnea despite using CPAP.
About Narcolepsy
Narcolepsy is a serious and debilitating
neurological condition that causes dysregulation of the sleep-wake
cycle and is characterized clinically by excessive daytime
sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis,
and disrupted nocturnal sleep. Narcolepsy afflicts an estimated
185,000 individuals in the U.S. Narcolepsy interferes with
cognitive, psychological, and social functioning, increases the
risk of work- and driving-related accidents, and is associated with
a 1.5-fold higher mortality rate.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical
company developing and delivering novel therapies for 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 newly acquired Sunosi product;
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 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 (including,
but not limited to, whether potential filing issues or issues
identified by FDA during the substantive review may impact the
potential approvability of the Company's NDA submission for AXS-05
in MDD or the timing of such approval; 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 potential for the ASCEND clinical trial, combined with the
GEMINI clinical trial results, to provide a basis for approval of
AXS-05 for the treatment of major depressive disorder and
accelerate its development timeline and commercial path to
patients; 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; the Company's anticipated capital requirements,
including the amount of capital required for the continued
commercialization of Sunosi and for the Company's commercial launch
of its product candidates, 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 Contact: Mark JacobsonChief Operating
Officer Axsome Therapeutics, Inc.22 Cortlandt Street, 16th FloorNew
York, NY 10007Tel: 212-332-3243Email: mjacobson@axsome.com
www.axsome.com
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