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 be presenting five abstracts at the upcoming
2023 American Academy of Neurology (AAN) Annual Meeting, being held
from April 22-27 in Boston. These presentations include new data
from the SHARP study, a randomized, double-blind,
placebo-controlled, crossover, multicenter trial in 59 patients
with excessive daytime sleepiness (EDS) associated with obstructive
sleep apnea (OSA) and impaired cognitive function, from which
positive topline results were announced in October 20221.
New data from the SHARP (Solriamfetol’s Effect
on Cognitive Health in Apnea Participants During a Randomized
Placebo-controlled) study being presented at AAN include detailed
secondary endpoints for the British Columbia Cognitive Complaints
Inventory (BC-CCI) and the Epworth Sleepiness Scale (ESS).
“The SHARP study is exciting because it
overcomes treatment barriers associated with the complex
relationship between cognitive impairment and OSA,” said Hans Van
Dongen, Ph.D., Professor at Washington State University and first
author of the SHARP study abstract. “Endpoints from the SHARP study
show potential clinical benefit for patients taking solriamfetol
versus placebo, suggesting it can be a robust option for the
treatment of patients with EDS due to OSA. These new data, and
other studies being shared at AAN, support the notion that
solriamfetol performs according to label specifications and has
potential to make a meaningful difference for patients with OSA and
excessive daytime sleepiness.”
Additional presentations at the AAN conference
highlight data on the TAAR1 agonist mechanism of action of
solriamfetol, data from the ongoing SURWEY real-world experience
study of Sunosi, as well as data on AXS-07, Axsome’s novel, oral,
rapidly absorbed, multi-mechanistic, investigational medicine for
the acute treatment of migraine.
Details for the upcoming AAN presentations are
as follows:
Title: Effects of Solriamfetol on Cognitive
Function in Participants with Cognitive Impairment Associated with
Excessive Daytime Sleepiness in Obstructive Sleep Apnea: Results of
the SHARP StudyPoster Session: P4 - Poster Session
4Presenting Author: Eileen Leary, Ph.D., Senior
Director of Clinical Development at
AxsomeDate/Time: Monday, April 24, 2023, from 8
a.m. – 9 a.m. ET
Title: Preclinical Pharmacology of
Solriamfetol: Potential Mechanisms for Wake PromotionPoster
Session: P4 - Poster Session 4Presenting
Author: Gregory S. Parks, Ph.D., Executive Director of
Medical Affairs at AxsomeDate/Time: Monday, April
24, 2023, from 8 a.m. – 9 a.m. ET
Title: Solriamfetol Real World Experience
Study: Initiation, Titration, Safety, Effectiveness, and Experience
During Follow-Up for Patients with Narcolepsy from
GermanyPoster Session: P4 - Poster Session
4Presenting Author: Samantha Floam, DMD, Director
of Medical Affairs at AxsomeDate/Time: Monday,
April 24, 2023, from 8 a.m. – 9 a.m. ET
Title: Identifying Areas of Unmet Need Among
People with Migraine with an Inadequate Response to Prior Acute
Therapies: Results from the MOMENTUM trialPoster
Session: P7 - Poster Session 7Presenting
Author: Zachariah Thomas, PharmD, MPH, Executive Director
of Medical Affairs at AxsomeDate/Time: Monday,
April 24, 2023, from 8 a.m. – 9 a.m. ET
Title: Efficacy of AXS-07 (MOSEIC™ Meloxicam
and Rizatriptan) in Patients with Risk Factors for Inadequate
Response to Acute Migraine MedicationsPoster
Session: P13 - Poster Session 13Presenting
Author: Stuart J. Tepper, MD, Professor of Neurology,
Geisel School of Medicine at DartmouthDate/Time:
Thursday, April 27, 2023, from 8 a.m. – 9 a.m. ET
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 an ongoing 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 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 AXS-07
AXS-07 is a novel, oral, rapidly absorbed,
multi-mechanistic investigational medicine for the acute treatment
of migraine, consisting of MoSEIC™ meloxicam and rizatriptan.
Meloxicam is a new molecular entity for migraine enabled by
Axsome's MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex)
technology, which results in rapid absorption of meloxicam while
maintaining a long plasma half-life. Meloxicam is a COX-2
preferential non-steroidal anti-inflammatory drug and rizatriptan
is a 5-HT1B/1D agonist. AXS-07 is designed to provide rapid,
enhances and consistent relief of migraine, with reduced symptom
recurrence. AXS-07 is protected by a robust patent estate extending
out to at least 2036. AXS-07 is not approved by the FDA.
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.22 Cortlandt Street,
16th FloorNew York, NY 10007Tel:
212-332-3243Email: mjacobson@axsome.comwww.axsome.com
Media:Darren OplandDirector, Corporate Communications Axsome
Therapeutics, Inc.22 Cortlandt Street, 16th FloorNew York, NY
10007Tel: 929-837-1065Email: dopland@axsome.com
www.axsome.com
References:
- Axsome
Therapeutics SHARP Study Topline Data Press Release, October 3,
2023:
https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-sunosir-solriamfetol-meets-primary
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