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 AUVELITY™ (dextromethorphan HBr-bupropion HCl) is
now available by prescription in the United States for the
treatment of major depressive disorder (MDD) in adults.1 AUVELITY
is the first and only oral N-methyl D-aspartate (NMDA) receptor
antagonist approved for the treatment of MDD, and the first and
only rapid-acting oral medicine approved for the treatment of MDD
with labeling of statistically significant antidepressant efficacy
compared to placebo starting at one week.1-4 AUVELITY was developed
with FDA Breakthrough Therapy designation for the treatment of MDD.
Rakesh Jain, MD, Clinical Professor, Department
of Psychiatry, of Texas Tech University School of Medicine said,
“Auvelity may shift the way physicians approach the treatment of
patients experiencing major depressive disorder due to its
differentiated clinical profile. Auvelity utilizes the first new
oral non-monoamine-based mechanism of action in more than six
decades approved for the treatment of major depressive disorder in
adults. Based on its demonstrated rapid action starting at one week
versus placebo, and its sustained effect, Auvelity represents an
important new treatment for patients suffering from this
debilitating and potentially life-threatening
condition.”
Michael Pollock, Chief Executive Officer of the
Depression and Bipolar Support Alliance (DBSA), a leading national
patient advocacy organization focusing on depression and bipolar
disorder said, “Our community of peers and their physicians welcome
any new innovations that can improve the experience of patients
living with depression. More than 20 million American adults
experienced major depressive disorder each year prior to the
COVID-19 pandemic, and the prevalence increased dramatically during
the pandemic with more than 80 million Americans experiencing
elevated depressive symptoms. Unfortunately, the majority of
patients treated with currently available antidepressants do not
adequately respond, highlighting the urgent need for novel
treatments. We appreciate Axsome’s commitment to research and
develop new medicines to address the needs of patients living with
mental health conditions.”
Lori Englebert, Executive Vice President,
Commercial and Business Development of Axsome said, “We are
thrilled to launch Auvelity and make this potentially life-changing
therapy available to adults with major depressive disorder. Our
highly experienced field team has begun active engagement with
healthcare providers and are utilizing our first-in-class Digital
Centric Commercialization, or DCC, platform. In clinical trials,
Auvelity has demonstrated symptom improvement starting at one week,
followed by achievement of remission in a substantial proportion of
treated patients with major depressive disorder. We are committed
to supporting access for patients to this important new therapy and
have instituted a comprehensive patient support program, which
includes a savings card for eligible patients and educational
resources to facilitate discussions between patients and their
physicians.”
AUVELITY (dextromethorphan HBr-bupropion HCl)
extended-release tablets 45mg/105mg was approved by the U.S. Food
and Drug Administration (FDA) on August 18th, 2022. The FDA granted
Breakthrough Therapy designation for AUVELITY for the treatment of
MDD in March 2019. This designation is granted to candidate drugs
that show potential for benefit above that of available therapies
based on preliminary clinical data on one or more clinically
significant endpoints for a serious or life-threatening condition,
and it provides the sponsor with added focus from and greater
interactions with FDA staff during the development of the candidate
drug.5 The AUVELITY New Drug Application (NDA) was evaluated by the
FDA under Priority Review, which is granted by the FDA to
applications for medicines that, if approved, would provide
significant improvements in the effectiveness or safety of the
treatment, diagnosis, or prevention of serious conditions when
compared to standard applications.
Antidepressants increase the risk of suicidal
thoughts and behaviors in pediatric and young adult patients.
AUVELITY is not approved for use in children.
Resources for Patients and Healthcare
Providers
For patients, Axsome provides robust and
comprehensive support services, including the AUVELITY Savings
Card, the Auvelity on My Side program, and telehealth services that
include nurse navigators to answer questions and assist in
scheduling visits with healthcare providers. The Company's AUVELITY
Savings Card reduces patient out-of-pocket costs for commercially
insured eligible patients who qualify. Axsome’s Auvelity On My Side
program provides patients educational resources and tools for
patients to facilitate discussions with their healthcare providers.
More information on the patient programs and services can be found
at auvelity.com. To receive an AUVELITY savings card, text “SAVE”
to 61489 or visit auvelity.com to access a QR code or sign-up by
email.
For U.S. healthcare providers, Axsome provides
educational sessions via our field force, a samples program, and
comprehensive payer assistance to help clinicians provide their
patients access to Auvelity. More information on the healthcare
provider programs and services can be found at auvelityhcp.com. To
order samples, healthcare providers can call 833-569-2224 or visit
auvelityhcp.com.
About Major Depressive Disorder
(MDD)
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 U.S. Department of Health and Human
Services, an estimated 21 million U.S. adults experienced MDD each
year.6 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 disease.7 Nearly
two-thirds of diagnosed and treated patients do not experience
adequate treatment response with available first-line treatment,8
highlighting the need for new therapies.
About the AUVELITY Clinical Development
Program in MDD
AUVELITY was studied in a comprehensive clinical
program which included more than 1,100 patients with depression.
The efficacy of AUVELITY in the treatment of MDD was demonstrated
in the GEMINI placebo-controlled study, and confirmatory evidence
which included the ASCEND study comparing AUVELITY to bupropion
sustained-release tablets. In the GEMENI study, AUVELITY was
statistically significantly superior to placebo in improvement of
depressive symptoms as measured by the change in the
Montgomery-Åsberg Depression Rating Scale (MADRS) total score at
Week 6, the study’s primary endpoint. To evaluate speed of onset of
action, the change in MADRS total score from baseline to Week 1 and
from baseline to Week 2 were pre-specified secondary efficacy
endpoints. The difference between AUVELITY and placebo in change
from baseline in MADRS total score was statistically significant at
Week 1 and at Week 2.1 In the ASCEND study, AUVELITY was
statistically significantly superior to bupropion sustained-release
tablets 105 mg twice daily on the primary outcome measure.9 The
primary outcome measure of the ASCEND study was calculated by
assessing the change from baseline in MADRS total scores from Week
1 to Week 6 and then taking the average of those scores.1 In the
placebo-controlled clinical study, the most common (incidence ≥5%
for AUVELITY and more than twice as frequently as placebo) adverse
reactions were dizziness, headache, diarrhea, somnolence, dry
mouth, sexual dysfunction, and hyperhidrosis.1
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 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 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 08/2022
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® product and the success
of our efforts to obtain any additional indication(s) with respect
to Sunosi; the commercial success of our Auvelity™ product and the
success of our efforts to obtain any additional indication(s) with
respect to 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 (including, but not limited to,; 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 product candidates,
if approved; the Company’s anticipated capital requirements,
including the amount of capital required for the successful
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 Contact:
Mark JacobsonChief Operating Officer Axsome Therapeutics, Inc.22
Cortlandt Street, 16th FloorNew York, NY 10007Tel:
212-332-3243Email: mjacobson@axsome.com www.axsome.com
References
- AUVELITY [Prescribing Information].
New York, NY: Axsome Therapeutics, Inc.
- Thomas D, et al. The state of
innovation in highly prevalent chronic diseases volume I:
Depression therapeutics. December 2017. Accessed March 21,
2022.
- FDA Depression Medicines.
https://www.fda.gov/media/132665/download. Accessed March 21,
2022.
- Machado-Vieira R, et al. Prog
Neurobiol 2017;152:21–37.
- Corrigan-Curay J, et al. N Engl J
Med 2018; 378:1457–1458.
- 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.
- Tabuteau H, et al. Am J Psychiatry
2022; 179(7):490-499.
PP-AUV-US-2200077 10/2022
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