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 Auvelity® (dextromethorphan-bupropion),
Sunosi® (solriamfetol), and disease state at the upcoming American
Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being
held from May 30-June 3 in Miami. The presentations on Auvelity
incorporate new data and post-hoc analyses including demonstration
of functional improvement in patients with major depressive
disorder (MDD). The presentations on Sunosi include data from the
SHARP (Solriamfetol’s Effect on Cognitive Health in Apnea
Participants During a Randomized Placebo-controlled) study
demonstrating improvement in cognitive function in patients with
excessive daytime sleepiness (EDS) associated with obstructive
sleep apnea (OSA).
“MDD is the leading cause of disability
worldwide and improvement in functioning is critically important to
people with MDD. Workplace costs, which are driven by presenteeism,
are the major driver of the total economic burden of MDD, which
exceeds $326 billion in the United States1,” said Andrew Cutler,
MD, Associate Clinical Professor of Psychiatry, SUNY Upstate
Medical University and Chief Medical Officer, Neuroscience
Education Institute. “These data add to the existing clinical
evidence for Auvelity in improving patient-centered outcomes in MDD
and demonstrate the potential for Auvelity to improve functional
impairment in MDD and to reduce key drivers of MDD-related
costs.”
Details for the upcoming ASCP presentations are
as follows:
Title: AXS-05 (Dextromethorphan-Bupropion)
Significantly Improved Functioning in Major Depressive Disorder:
Analysis of the Domains of the Sheehan Disability ScaleOral
Session: Poinciana 1 2Lead Author: Andrew
Cutler, MD, SUNY Upstate Medical University and Neuroscience
Education InstituteDate/Time: Tuesday, May 30,
2023, from 4:15 p.m. – 4:30 p.m. ET
Title: Impact of AXS-05
(Dextromethorphan-Bupropion) on Patient-Reported Insomnia Symptoms:
Results from the GEMINI TrialPoster Session: Salon
4Lead Author: Zachariah Thomas, PharmD, MPH,
Axsome TherapeuticsDate/Time: Wednesday,
Wednesday, May 31, 2023, from 11:15 a.m. – 1 p.m. ET
Title: Assessment of Withdrawal Symptoms After
Discontinuation of AXS-05 (Dextromethorphan-Bupropion) Treatment:
Results from the GEMINI TrialPoster Session: Salon
4Lead Author: Rakesh Jain, MD Texas Tech
University School of Medicine-Permian
BasinDate/Time: Thursday, June 1, 2023, from 12:30
p.m. – 2:15 p.m. ET
Title: Major Depressive Disorder Disease and
Patient Characteristics Associated with Inadequate Treatment
Experience: Results from the SUPPORT StudyPoster
Session: Salon 4Lead Author: Gregory
Mattingly, MD, Associate Clinical Professor of Psychiatry at
Washington University and President of the Midwest Research
GroupDate/Time: Thursday, June 1, 2023, from 12:30
p.m. – 2:15 p.m. ET
Title: Excessive Daytime Sleepiness in a
Real-World Study of Participants with Obstructive Sleep Apnea with
or without Comorbid DepressionPoster Session:
Salon 4Lead Author: Samantha Floam, DMD, Axsome
TherapeuticsDate/Time: Thursday, June 1, 2023,
from 12:30 p.m. – 2:15 p.m. ET
Title: Preclinical Pharmacology of
Solriamfetol: Potential Mechanisms for Wake PromotionPoster
Session: Salon 4Lead Author: Gregory
Parks, PhD, Axsome TherapeuticsDate/Time:
Thursday, June 1, 2023, from 12:30 p.m. – 2:15 p.m. ET
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: Salon 4Lead
Author: Eileen Leary, PhD, Axsome
TherapeuticsDate/Time: Wednesday, May 31, 2023,
from 11:15 a.m. – 1 p.m. ET
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 year2. 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 disease3. Nearly two-thirds of diagnosed and treated patients do
not experience adequate treatment response with currently available
first-line therapy4, 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 10/2022Please see
full Prescribing Information, including Boxed
Warning for suicidal thoughts and behaviors,
and Medication Guide.
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.com
www.axsome.com
References:
- Greenberg PE, et
al. The Economic Burden of Adults with Major Depressive Disorder in
the United States (2010 and 2018). Pharmacoeconomics. 2021
Jun;39(6):653-665. doi: 10.1007/s40273-021-01019-4. Epub 2021 May
5. PMID: 33950419; PMCID: PMC8097130.
- Substance Abuse
and Mental Health Services Administration. (2022). Key substance
use and mental health indicators in the United States: Results from
the 2021 National Survey on Drug Use and Health (HHS Publication
No. PEP22-07-01-005, NSDUH Series H-57). Center for Behavioral
Health Statistics and Quality, Substance Abuse and Mental Health
Services Administration
- World Health
Organization. Depression and Other Common Mental Disorders: Global
Health Estimates. Geneva: World Health Organization; 2017.
- Rush AJ, et al.
Am J Psychiatry. 2006;163:1905-1917.
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