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 data from its industry-leading portfolio of novel
products for CNS disorders will be presented at the 2024 American
Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being
held May 28-31, 2024, in Miami Beach, Florida.
The presentations include new data from post-hoc
analyses of Auvelity® showing improvements in anhedonic symptoms
that strongly correlate with improvements in daily function in
patients with major depressive disorder (MDD) and data on the
clinical profile of AXS-05 in treatment of Alzheimer’s disease
agitation.
Details for the presentation are as follows:
Major Depressive Disorder
Title: Effects of AXS-05
(Dextromethorphan-Bupropion) in Improving Anhedonia and
Interest-Activity Symptoms of MDD and the Associated Improvements
in Functional ImpairmentPresentation Date and
Time: Wednesday, May 29, 11:15 a.m. – 1 p.m.Lead
Author: Roger McIntyre, MD, Professor of Psychiatry and
Pharmacology at the University of TorontoPoster
Number: W17Location: Salon 4
Title: Real-World AXS-05
Patient Characteristics in Major Depressive
DisorderPresentation Date and Time: Wednesday, May
29, 11:15 a.m. – 1 p.m.Lead Author: Andrew Muzyk,
MD, Associate Professor of the Practice of Medical Education at
Duke UniversityPoster Number:
W40Location: Salon 4
Alzheimer’s Disease
Agitation
Title: Clinical Profile of
AXS-05 (Dextromethorphan-Bupropion) in Treating Alzheimer’s Disease
Agitation (ADA): Results From The Phase 2/3 Development
ProgramPresentation Date and Time: Wednesday, May
29, 11:15 a.m. – 1 p.m.Lead Author: Jeffrey
Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain
HealthPoster Number: W47Location:
Salon 4
Cognition
Title: Solriamfetol Improves
Cognitive Performance in Preclinical Models of Sleep Apnea and in a
Randomized Placebo-controlled Study of Sleep Apnea Participants
(SHARP)Presentation Date and Time: Thursday, May
30, 12:30 p.m. – 2:15 p.m.Lead Author: David
Gozal, MD, MBA, Marie M. and Harry L. Smith Endowed Chair and the
Chairman of the Department of Child Health at the University of
Missouri Poster Number:
T38Location: Salon 4
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 geo-political
conflicts or a global pandemic 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
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