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 treatment with AUVELITY® (dextromethorphan
HBr-bupropion HCl) resulted in rapid, substantial, and durable
improvements in cognitive and physical functioning in the EVOLVE
open-label trial in major depressive disorder (MDD). Treatment with
AUVELITY also resulted in reduced disability. These new data were
presented yesterday at the American College of
Neuropsychopharmacology (ACNP) 2022 Annual Meeting being held in
In the trial, AUVELITY rapidly, durably, and
substantially improved symptoms of depression including cognitive
and physical functioning, and reduced disability in patients with
MDD who had received one or more prior antidepressants. The change
in cognitive and physical functioning was assessed using the
Massachusetts General Hospital (MGH) Cognitive and Physical
Functioning Questionnaire (CPFQ), a patient-rated scale used to
measure cognitive and executive dysfunction in mood and anxiety
disorders. The mean CPFQ score at baseline was 28.4. Mean
improvements from baseline to weeks 1, 2, and 6 in CPFQ scores were
-2.0 points, -4.4 points, and -7.5 points, respectively (p<0.001
for all). Improvements on the CPFQ were sustained through month 6
(-9.5 points, p<0.001) and month 12 (-8.5 points, p<0.001).
Disability was assessed using the Sheehan Disability Scale (SDS), a
patient-facing questionnaire used to evaluate impairments in the
domains of work, social life/leisure, and family life/home
responsibility. The mean SDS score at baseline was 17.5. Mean
improvements from baseline to weeks 1, 2, and 6 in SDS scores were
-2.9 points, -5.0 points, and -8.3 points, respectively (p<0.001
for all). Improvements on the SDS were sustained through month 6
(-10.1 points, p<0.001) and month 12 (-10.8 points,
EVOLVE (Evaluation of NMDA Modulation for
Depressive Episodes) was an open-label, U.S. trial in which 146
patients with MDD who had received one or more prior
antidepressants were treated with AUVELITY twice daily for up to 15
months. The primary endpoint was the change from baseline to week 6
on the Montgomery-Ǻsberg Depression Rating Scale (MADRS) total
score. Statistical analysis was performed comparing the measures at
each timepoint to baseline values as pre-specified (significance
level of 0.05, two-sided). AUVELITY was generally well tolerated
with long-term treatment and exhibited a safety profile consistent
with that observed in previously reported trials. The most common
adverse events were COVID-19 infection (8.9%), nausea (8.9%),
headache (7.5%), dry mouth (6.2%), dizziness (5.5%), and insomnia
Details of the poster presentation are as
Title: Improvements in Cognitive and Physical
Functioning Outcomes in Depressed Patients Treated with AXS-05
(Dextromethorphan-Bupropion): Results from the EVOLVE Open-label,
Long-Term StudyPoster Number: T122Session: Poster Session II,
December 6, 2022
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 U.S. Department of Health and Human
Services, an estimated 21 million U.S. adults experienced MDD each
year.1 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.2 Nearly
two-thirds of diagnosed and treated patients do not experience
adequate treatment response with available first-line treatment,3
highlighting the need for new therapies.
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
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
- 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
or had a seizure disorder.
or had an eating disorder like anorexia or bulimia.
recently and suddenly stopped drinking alcohol or use medicines
called benzodiazepines, barbiturates, or anti-seizure medicines,
and you have recently suddenly stopped taking them.
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
allergic to dextromethorphan, bupropion, or any other ingredients
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
Manic episodes. Manic episodes
may happen in people with bipolar disorder who take Auvelity.
Symptoms may include:
greatly increased energy
unusually grand ideas
talking more or faster than usual
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
body temperature (hyperthermia)
shaking (tremors), stiff muscles, or muscle twitching
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.
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
- other medicines
containing bupropion or dextromethorphan
- medicines to
treat depression, anxiety, psychotic or thought disorders,
including selective serotonin reuptake inhibitors (SSRIs) and
- oral diabetes
medicines or use insulin to control your blood sugar
- medicines to
control appetite (anorectic)
medicines to help you stop smoking
- street (illicit)
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
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
Tell your HCP about all your medical
conditions, including if you:
problems with your liver or kidneys.
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
low blood sugar, low blood sodium levels, or a history of
take certain other medicines that could interact with
or had a condition known as bipolar disorder, a family history of
bipolar disorder, suicide, or depression.
high pressure in the eye (glaucoma).
Review the list below with your HCP.
Auvelity may not be right for you if:
drink a lot of alcohol.
abuse prescription or street drugs.
are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed.
HOW TO TAKE
Auvelity is available by prescription only.
Auvelity exactly as instructed by your HCP.
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
Swallow Auvelity tablets whole. Do not crush, chew, or divide the
- Do not
give Auvelity to other people.
- If you
take too much Auvelity call your HCP or seek medical advice
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
AUV CON BS 10/2022
Please see full Prescribing Information,
including Boxed Warning for suicidal thoughts and
behaviors, and Medication Guide.
About Axsome Therapeutics,
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
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
Axsome Contact: Mark JacobsonChief Operating
Officer Axsome Therapeutics, Inc.22 Cortlandt Street, 16th FloorNew
York, NY 10007Tel: 212-332-3243Email: firstname.lastname@example.org
- 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
- Wardenaar KJ, et al. J. Affect.
Disord 2012; 136:1198-1203.
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