Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
announced presentations on Sunosi® (solriamfetol) at SLEEP 2023,
the annual meeting of the American Academy of Sleep Medicine and
the Sleep Research Society, being held in Indianapolis, Ind., from
June 3-7, 2023. The presentations include new data from the SHARP
(Solriamfetol’s Effect on Cognitive Health in Apnea Participants
During a Randomized Placebo-controlled) study in patients with
excessive daytime sleepiness (EDS) associated with obstructive
sleep apnea (OSA), demonstrating sustained improvement with Sunosi
on measures of cognition across 8-hours with once daily dosing.
Additional new data and analyses include real-world data from OSA
patients taking Sunosi as part of the SURWEY study in Germany,
healthcare resource use in OSA patients with residual EDS, and
effect sizes and numbers needed to treat analyses.
“Cognitive impairment is a substantial burden to
many patients with EDS and OSA. The results of the SHARP study are
particularly exciting because they demonstrate a robust improvement
in cognitive function that was sustained throughout the day,” said
Hans Van Dongen, PhD, Professor at Washington State University and
first author of the SHARP study abstract. “Not only was there an
objective change in cognitive performance, but patients also
reported a measurable improvement in their symptoms, suggesting
solriamfetol can be an effective option for the treatment of
patients with EDS due to OSA.”
Details for the upcoming SLEEP Meeting
presentations are as follows:
Title: Solriamfetol Demonstrates Durable
Cognitive Improvement in Adults with Obstructive Sleep Apnea and
Excessive Daytime Sleepiness Poster Session:
P-29
Lead Author: Hans Van Dongen,
PhD, Professor at Washington State University
Date/Time: June 6, 2023, from 5:00 – 6:00 p.m.
Eastern TimePoster Board Number: 168
Title: SURWEY Study of Solriamfetol:
Initiation, Titration, Safety, Efficacy, and Follow-Up Experience
for Patients with OSA in German Poster Session:
P-29
Lead Author: Yaroslav Winter,
MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center,
Department of Neurology, Johannes Gutenberg-University, Mainz,
GermanyDate/Time: June 6, 2023, from 12:00 – 1:15
p.m. Eastern TimePoster Board Number: 169
Title: Solriamfetol for Excessive Sleepiness in
Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers
Needed to Treat or Harm Poster Session: P-29
Lead Author: Russell Rosenberg,
PhD, NeuroTrials Research, Atlanta, GADate/Time:
June 6, 2023, from 5:00 – 6:00 p.m. Eastern TimePoster
Board Number: 170
Title: Healthcare Resource Utilization Burden 1
Year Post Continuous Positive Airway Pressure Initiation Among
Adults with Excessive Daytime Sleepiness in Obstructive Sleep Apnea
in the United Kingdom Poster Session:
P-12Lead Author: Gregory Parks, PhD, Axsome
Therapeutics
Date/Time: June 6, 2023, from
12:00 – 1:15 p.m. Eastern TimePoster Board Number:
229
About the SHARP Trial
SHARP (Solriamfetol’s Effect on Cognitive Health
in Apnea Participants During a Randomized Placebo-controlled Study)
was a randomized, double-blind, placebo-controlled, crossover,
multicenter, trial in which 59 patients with EDS and OSA, who were
experiencing cognitive impairment, were all treated with Sunosi
(solriamfetol) for 2 weeks, and with placebo for 2 weeks, with the
treatment periods separated by a 1 week washout. Patients were
randomized in a 1:1 ratio either to treatment with Sunosi followed
by placebo (sequence 1), or to treatment with placebo followed by
Sunosi (sequence 2). Sunosi was administered orally once daily,
starting at 75 mg per day for the first three days and 150 mg per
day for the remainder of the 2-week treatment period. The primary
outcome measure was the Digit Symbol Substitution Test subtest of
the Repeatable Battery for the Assessment of Neuropsychological
Status (DSST RBANS). The Digit Symbol Substitution subtest is also
referred to as “Coding.” The prespecified primary endpoint was the
change from baseline in cognitive function as measured by the DSST
RBANS after 2 weeks of treatment (average of the 2-, 4-, 6-, and
8-hour post-dose DSST RBANS scores). Secondary endpoints included
patient reported measures of cognition including the British
Columbia Cognitive Complaints Inventory (BC-CCI) and the Patient
Global Impression of Severity (PGI-S) for cognitive symptoms; and
the Epworth Sleepiness Scale (ESS) to measure wakefulness. The
secondary endpoints were analyzed in a pre-specified testing
sequence. All analyses were conducted on an intent-to-treat
basis.
About the SUnosi Real World Experience
studY (SURWEY) Study
SURWEY is a retrospective chart review among
physicians in Germany, prescribing solriamfetol for patients with
EDS associated with narcolepsy or OSA. Physicians prescribing
solriamfetol to ≥10 patients with EDS associated with narcolepsy
can take part and provide data from the patients’ medical records.
Eligible patients are ≥18 years old, have been diagnosed with EDS
associated with narcolepsy, achieve a stable dose on solriamfetol,
and complete ≥6 weeks of solriamfetol treatment. Data related to
solriamfetol dosing/titration, changes in Epworth Sleepiness Scale
(ESS) scores, physician and patient impression of effectiveness,
and adverse events are recorded and summarized descriptively. The
present analysis focuses on data from patients with narcolepsy from
Germany.
About Sunosi®
(solriamfetol)
Sunosi is a dual-acting dopamine and
norepinephrine reuptake inhibitor indicated to improve wakefulness
in adult patients with excessive daytime sleepiness (EDS)
associated with narcolepsy or obstructive sleep apnea (OSA). Sunosi
does not treat the underlying cause of OSA and Sunosi does not take
the place of any device prescribed for OSA, such as a continuous
positive airway pressure (CPAP) machine. It is important that you
continue to use these treatments as prescribed by your healthcare
provider. 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. Sunosi is protected by a robust patent estate
with expiries out to 2040.
More information about Sunosi, including
Full Prescribing Information and Medication Guide, is
available here.
Important Safety
Information
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.
Do not take SUNOSI if you are
taking, or have stopped taking within the past 14 days, a medicine
used to treat depression called a monoamine oxidase inhibitor
(MAOI).
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.
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.
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 see here for full Prescribing
Information.
SUN CON ISI 05/2022
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 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, 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.comwww.axsome.com
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