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 of data from its CNS portfolio at the 2023
U.S. Psych Congress, being held in Nashville, Tenn. from September
6-10. The presentations demonstrate the Company’s commitment to
continued innovation to address unmet needs in difficult-to-treat
CNS disorders.
“Axsome’s presentations at Psych Congress
highlight our commitment to advancing research of medicines that
have the potential to improve the lives of patients with brain
health conditions such as depression and sleep disorders,” said
Cecilia Brain, MD, PhD, Vice President of Medical Affairs at
Axsome. “These presentations explore the meaningful impact that our
treatments could have for patients and underscore the unique
pharmacology of our novel medicines which may be relevant to
multiple clinical conditions.”
The presentations will include eight posters
with data and analyses which examine the effects of AUVELITY®
(dextromethorphan-bupropion) on sleep quality and cognitive and
physical functioning in patients with major depressive disorder
(MDD), and the effects of SUNOSI® (solriamfetol) on cognition in
patients with excessive daytime sleepiness (EDS) due to obstructive
sleep apnea (OSA). Five of the eight posters are finalists under
consideration for the Psych Congress Poster Awards.
Key highlights include:
- Data
examining durability of efficacy and tolerability with long-term
(up to 12 months) treatment with AUVELITY in patients with MDD,
including measures of depressive symptoms, anxiety, and cognitive
and physical functioning.
- Data examining
the effect of AUVELITY on depression-related disability, and
patient-reported measures of insomnia in patients with MDD.
- Data examining
treatment effect sizes of SUNOSI in patients with EDS associated
with narcolepsy and OSA.
- Data examining
the effects of SUNOSI on cognition in patients with EDS and
OSA.
All posters will be presented on September 8 and
9 from 1:30-3 p.m. Central Time in Exhibit Hall A and B. An
asterisk ahead of the title (*) indicates presentations under
consideration as finalists for the Psych Congress Poster Awards,
being presented from 6:45-8 p.m. Central Time on September 9.
Details for the presentations are as follows:
Major Depressive
Disorder:
* Title: AXS-05
(Dextromethorphan-Bupropion) Significantly Improved Functioning in
Major Depressive Disorder: Analysis of the Domains of the Sheehan
Disability Scale Lead Author: Andrew Cutler, MD,
SUNY Upstate Medical University and Neuroscience Education
InstitutePoster Number: 44
* Title: Improvements in
Cognitive and Physical Functioning Outcomes in Depressed
Individuals Treated with AXS-05 (Dextromethorphan-Bupropion):
Results from the EVOLVE Open-Label, Long-Term Study Lead
Author: Maurizio Fava, MD, Director, Division of Clinical
Research, Massachusetts General Hospital (MGH) Research
InstitutePoster Number: 51
Title: Assessment of Withdrawal
Symptoms After Discontinuation of AXS-05
(Dextromethorphan-Bupropion) Treatment: Results From the GEMINI
Trial Lead Author: Rakesh Jain, MD, Texas Tech
University School of Medicine-Permian BasinPoster
Number: 71
Title: Impact of AXS-05
(Dextromethorphan-Bupropion) on Patient-Reported Insomnia Symptoms:
Results From the GEMINI Trial Lead Author: Manish
Jha, MD, O'Donnell Clinical Neuroscience Scholar Center for
Depression Research and Clinical CarePoster
Number: 73
Excessive Daytime Sleepiness in
Obstructive Sleep Apnea and
Narcolepsy:
* 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 StudyLead
Author: Hans Van Dongen, PhD, Washington State
UniversityPoster Number: 32
* Title: Solriamfetol Improves
Cognitive Performance in Preclinical Models of Sleep Apnea and in a
Randomized Placebo-Controlled Study of Sleep Apnea Participants
(SHARP)Lead Author: David Gozal, MD, University of
MissouriPoster Number: 33
* Title: Solriamfetol for
Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea:
Effect Sizes and Numbers Needed to Treat or HarmLead
Author: Craig Chepke, MD, SUNY Upstate Medical
UniversityPoster Number: 45
Title: SURWEY Study of
Solriamfetol: Initiation, Titration, Safety, Efficacy, and
Follow-Up Experience for Patients With OSA in GermanyLead
Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy
and Sleep Medicine Center, Department of Neurology, Johannes
Gutenberg-University, Mainz, GermanyPoster Number:
99
INDICATION AND IMPORTANT SAFETY
INFORMATION
WHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a
prescription oral medicine used to treat adults with major
depressive disorder (MDD). It is not known if Auvelity is safe and
effective for use in children.Auvelity is not approved for uses
other than the treatment of MDD. The ingredients in Auvelity,
bupropion and dextromethorphan, are the same ingredients found in
some other medicines approved for other uses.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD
KNOW ABOUT AUVELITY?Auvelity and other antidepressant medicines may
increase suicidal thoughts and actions in some children,
adolescents, and young adults, especially within the first few
months of treatment or when the dose is changed. Auvelity is
not for use in children.You should pay close attention to any new
or sudden changes in mood, behavior, thoughts, or feelings or if
you develop suicidal thoughts or actions. This is very important
when starting or changing the dose of an antidepressant
medicine.Call your healthcare provider (HCP) or get emergency help
right away if you or your loved one have any of the following
symptoms, especially if they are new, worse, or worry you:
-
suicidal thoughts or actions
- new or
worsening depression or anxiety
-
agitation or restlessness
-
trouble sleeping (insomnia)
- acting
aggressive, being angry violent
- an
extreme increase in activity and talking (mania)
- panic
attacks
- new or
worsening irritability
- acting
on dangerous impulses
- other
unusual changes in behavior or mood
Do not take Auvelity if you:
- have or had a
seizure disorder.
- have or had an
eating disorder like anorexia or bulimia.
- have recently
and suddenly stopped drinking alcohol or use medicines called
benzodiazepines, barbiturates, or anti-seizure medicines, and you
have recently suddenly stopped taking them.
- are taking a
monoamine oxidase inhibitor (MAOI), have stopped taking an MAOI in
the last 14 days, or are being treated with the antibiotic
linezolid or intravenous methylene blue. Ask your HCP or pharmacist
if you are unsure whether you take an MAOI. Do not start taking an
MAOI until you have stopped taking Auvelity for at least 14
days.
- are allergic to
dextromethorphan, bupropion, or any other ingredients in
Auvelity.
Auvelity may cause serious side effects. Ask
your HCP how to recognize the serious side effects below and what
to do if you think you have one:Seizures. There is a risk of
seizures during treatment with Auvelity. The risk is higher if you
take higher doses of Auvelity, have certain medical problems, or
take Auvelity with certain other medicines. Do not take
Auvelity with other medicines unless your healthcare provider tells
you to.If you have a seizure during treatment with Auvelity, stop
taking Auvelity and call your HCP right away. Do not take
Auvelity again if you have a seizure.Increases in blood pressure
(hypertension). Some people may get high blood pressure during
treatment with Auvelity. Your HCP should check your blood pressure
before you start taking and during treatment with Auvelity.Manic
episodes. Manic episodes may happen in people with bipolar
disorder who take Auvelity. Symptoms may include:
- greatly
increased energy
- racing
thoughts
- unusually grand
ideas
- talking more or
faster than usual
- severe trouble
sleeping
- reckless
behavior
- excessive
happiness or irritability
Unusual thoughts or behaviors. One of the
ingredients in Auvelity (bupropion) can cause unusual thoughts or
behaviors, including delusions (believing you are someone else),
hallucinations (seeing or hearing things that are not there),
paranoia (feeling that people are against you), or feeling
confused. If this happens to you, call your HCP.Eye problems
(angle-closure glaucoma). Auvelity may cause a type of eye
problem called angle-closure glaucoma in people with certain other
eye conditions. You may want to undergo an eye examination to see
if you are at risk and receive preventative treatment if you are.
Call your HCP if you have eye pain, changes in your vision, or
swelling or redness in or around the eye.Dizziness. Auvelity
may cause dizziness which may increase your risk for
falls.Serotonin syndrome. A potentially life-threatening
problem called serotonin syndrome can happen when you take Auvelity
with certain other medicines. Call your HCP or go to the
nearest hospital emergency room right away if you have any of
the following signs and symptoms:
- agitation
-
hallucinations
- confusion
- coma
- fast
heartbeat
- blood pressure
changes
- dizziness
- sweating
- flushing
- high body
temperature (hyperthermia)
- shaking
(tremors), stiff muscles, or muscle twitching
- loss of
coordination
- seizures
- nausea,
vomiting, diarrhea
COMMON SIDE EFFECTS
The most common side effects of Auvelity
include dizziness, headache, diarrhea, feeling sleepy, dry
mouth, sexual function problems, and excessive sweating.These are
not all the possible side effects of Auvelity. Tell your doctor if
you have any side effects. You can report side effects at
1-800-FDA-1088 or www.fda.gov/medwatch.
BEFORE USING
- Tell
your HCP about all the medicines you take, including prescription
and over-the-counter medicines, vitamins, and herbal
supplements.
- It is
important to tell your HCP if you are taking:
- other medicines
containing bupropion or dextromethorphan
- medicines to
treat depression, anxiety, psychotic or thought disorders,
including selective serotonin reuptake inhibitors (SSRIs) and
tricyclic antidepressants
-
theophylline
-
corticosteroids
- oral diabetes
medicines or use insulin to control your blood sugar
- medicines to
control appetite (anorectic)
- nicotine
medicines to help you stop smoking
- street (illicit)
drugs
- benzodiazepines,
sedative-hypnotic (sleep medicines), or opiates
- If you
are unsure if you take any of these medicines, ask your HCP. They
can tell you if it is safe to take Auvelity with your other
medicines.
- Tell
your HCP if you are pregnant or plan to become pregnant. Auvelity
may harm your unborn baby if you take it during pregnancy. Auvelity
is not recommended during pregnancy. Your HCP will prescribe
another treatment for females who plan to become
pregnant.
- One of
the ingredients in Auvelity passes into your breast milk. Do not
breastfeed during treatment with Auvelity and for 5 days after the
final dose.
Tell your HCP about all your medical
conditions, including if you:
- have problems
with your liver or kidneys.
- have diabetes,
heart disease, or high blood pressure.
- have a history
of seizure, stroke, eating disorder, head injury, or have a tumor
in your brain or spinal cord.
- have a history
of alcohol or drug abuse.
- have a history
of seizure, eating disorder, or abuse alcohol or drugs.
- have low blood
sugar, low blood sodium levels, or a history of falls.
- you take certain
other medicines that could interact with Auvelity.
- have or had a
condition known as bipolar disorder, a family history of bipolar
disorder, suicide, or depression.
- have high
pressure in the eye (glaucoma).
Review the list below with your HCP.
Auvelity may not be right for you if:
- you drink a lot
of alcohol.
- you abuse
prescription or street drugs.
- you are pregnant
or plan to become pregnant.
- you are
breastfeeding or plan to breastfeed.
HOW TO TAKE
- Auvelity is
available by prescription only.
- Take Auvelity
exactly as instructed by your HCP.
- Take Auvelity 1
time a day for 3 days, then increase your dose to 2 times a day
(taken at least 8 hours apart). Do not take more than 2 Auvelity
tablets in 24 hours.
- If you miss a
dose, do not take an extra dose. Wait and take your next dose at
the regular time. Do not take more than 1 dose of
Auvelity at a time.
- Do not change
your dose or stop taking Auvelity without talking to your HCP.
- Swallow Auvelity
tablets whole. Do not crush, chew, or divide the tablets.
- Do not give
Auvelity to other people.
- If you take too
much Auvelity call your HCP or seek medical advice promptly.
LEARN MORE
For more information about Auvelity,
call 866-496-2976 or visit Auvelity.com.This summary
provides basic information about Auvelity but does not include all
information known about this medicine. Read the information that
comes with your prescription each time your prescription is filled.
This information does not take the place of talking with your
doctor. Be sure to talk to your doctor or other HCP about Auvelity
and how to take it. Your HCP is the best person to help you decide
if Auvelity is right for you.
AUV CON BS 10/2022Please see
full Prescribing Information, including Boxed
Warning for suicidal thoughts and behaviors,
and Medication Guide.
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 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/or data readouts, 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 statements
regarding the timing of any NDA submission; 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.com
www.axsome.com
Media:
Darren OplandDirector, Corporate
CommunicationsAxsome Therapeutics, Inc.One World Trade Center, 22nd
FloorNew York, NY 10007Tel: 929-837-1065Email: dopland@axsome.com
www.axsome.com
Axsome Therapeutics (NASDAQ:AXSM)
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