Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
announced new data that treatment with Auvelity®
(dextromethorphan-bupropion) was associated with improvement in
quality of life outcomes in broad populations of depression
patients in the EVOLVE open-label trial in major depressive
disorder (MDD). These new data were presented at the American
College of Neuropsychopharmacology (ACNP) 2023 Annual Meeting, held
in Tampa, Florida, from Dec. 3-6, 2023.
An evaluation of interest and activity levels of
individuals with MDD following treatment with Auvelity in a pooled
post-hoc analysis of the placebo-controlled GEMINI and
active-controlled ASCEND studies, and an analysis of potential
withdrawal symptoms following discontinuation of Auvelity treatment
in the GEMINI trial were also presented.
“Depression exacts an extraordinary impact on
affected individuals especially by impairing enjoyment in
activities and role function,” said Roger McIntyre, MD, FRCPC,
Professor of Psychiatry and Pharmacology at the University of
Toronto and lead author. “These data exploring the improvements of
interest and activity following treatment with Auvelity are
compelling and have important clinical implications, especially
with respect to improvement in functional outcomes in patients with
MDD.”
Details of the poster presentations are as
follows:
Title: Evaluation of AXS-05
(dextromethorphan-Bupropion) in Major Depressive Disorder Using the
Interest-Activity DomainLead Author: Roger
McIntyre, MD, Professor of Psychiatry and Pharmacology, University
of Toronto, CanadaPoster Session: III
Title: Impact of AXS-05
(dextromethorphan-Bupropion) on Depressive Symptoms, Anxiety, and
Quality of Life in Patients With One Prior Treatment Failure:
Results from the Evolve Long-Term, Open-Label Study Lead
Author: Greg Mattingly, MD, Associate Clinical Professor
of Psychiatry at Washington University and President of the Midwest
Research Group Poster Session: I
Title: Assessment of Withdrawal
Symptoms After Discontinuation of AXS-05
(Dextromethorphan-Bupropion) Treatment: Results From the Gemini
TrialLead Author: Rakesh Jain, MD, Clinical
Professor, Department of Psychiatry, of Texas Tech University
School of Medicine Poster Session: III
About Major Depressive Disorder
Major depressive disorder (MDD) is a
debilitating, chronic, biologically based disorder characterized by
low mood, inability to feel pleasure, feelings of guilt and
worthlessness, low energy, and other emotional and physical
symptoms, and which impairs social, occupational, educational, or
other important functioning. In severe cases, MDD can result in
suicide. According to the National Institutes of Health, an
estimated 8.3% of U.S. adults, or approximately 21 million,
experience MDD each year1. According to the World Health
Organization (WHO), depression is the leading cause of disability
worldwide, and is a major contributor to the overall global burden
of disease2. Nearly two-thirds of diagnosed and treated patients do
not experience adequate treatment response with currently available
first-line therapy3, highlighting the need for additional therapies
with new mechanisms of action.
About AUVELITY®
AUVELITY is a novel, oral, NMDA receptor
antagonist with multimodal activity approved for the treatment of
MDD in adults. AUVELITY is a proprietary extended-release oral
tablet containing dextromethorphan HBr (45 mg) and bupropion HCl
(105 mg). The dextromethorphan component of AUVELITY is an
antagonist of the NMDA receptor (an ionotropic glutamate receptor)
and a sigma-1 receptor agonist. These actions are thought to
modulate glutamatergic neurotransmission. The bupropion component
of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to
increase and prolong the blood levels of dextromethorphan. The
exact mechanism of action of Auvelity in the treatment of
depression is unclear. AUVELITY received Breakthrough Therapy
designation from the FDA for the treatment of MDD.
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 10/2022
Please see full Prescribing Information,
including Boxed Warning for suicidal thoughts and
behaviors, and Medication Guide.
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
References:
- U.S. Department of Health and Human Services. Key Substance Use
and Mental Health Indicators in the United States: Results from the
2020 National Survey on Drug Use and Health. Published October
2021.
- Baune BT, et al. Neuropsychiatr Dis Treat
2021;17:2995-3006.
- Wardenaar KJ, et al. J. Affect. Disord 2012;
136:1198-1203.
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