Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
announced preliminary net product revenue for the fourth quarter
and full year ended December 31, 2023.
“Axsome completed its first full year as a
commercial company in 2023 and, during that time, our medicines
reached approximately 100,000 unique patients. Prescriptions for
Auvelity and Sunosi totaled more than 236,000 and 139,000,
respectively for the full year,” said Herriot Tabuteau, MD, Chief
Executive Officer of Axsome. “Looking ahead, 2024 promises to be a
busy year for us with an increased field force effort that will
support continued strong commercial execution with Auvelity and
Sunosi. We also anticipate multiple important clinical and
regulatory milestones from our industry leading neuroscience
portfolio in 2024. These include topline results from Phase 3
trials in narcolepsy, Alzheimer’s disease agitation, and ADHD, NDA
resubmission and submission for migraine and fibromyalgia,
respectively, and initiation of Phase 3 trials in major depressive
disorder, binge eating disorder, and excessive sleepiness
associated with shift work disorder. Collectively, Axsome has the
potential to address conditions that impact the lives of more than
150 million patients in the U.S. We are committed to developing and
delivering innovative treatments with novel mechanisms of action to
address unmet medical needs in serious conditions that affect brain
health.”
Preliminary Fourth Quarter and Full Year
2023 Net Product Revenue (Unaudited)
Based on preliminary unaudited financial
information, Axsome expects total product revenue to be
approximately $71 million and $204 million for the fourth quarter
and full year of 2023, respectively.
- Auvelity® net
product sales are expected to be approximately $49 million and $130
million for the fourth quarter and full year of 2023,
respectively.
- Sunosi® net
product revenue is expected to be $22 million and $74 million for
the fourth quarter and full year of 2023, respectively. Net product
revenue excludes $66 million in license revenue recognized by
Axsome in the first quarter of 2023.
The foregoing information reflects the Company's
estimate with respect to net product revenue for Auvelity and
Sunosi based on currently available unaudited information. This
announcement is not a comprehensive statement of Axsome’s financial
results and is subject to completion of Axsome’s financial closing
procedures. Axsome’s final financial results will be issued upon
completion of its closing procedures and may vary from these
preliminary estimates.
2024 Development Pipeline Anticipated
Milestones
Axsome is advancing an industry-leading
neuroscience portfolio encompassing five innovative late-stage
product candidates for 10 serious conditions, which affect more
than 150 million people in the U.S. alone. 2024 anticipated
milestones for key pipeline programs are summarized below.
-
Regulatory Milestones:
- AXS-07 for
migraine, NDA resubmission (1H 2024)
- AXS-14 for
fibromyalgia, NDA submission (1Q 2024)
-
Clinical Trial Topline Results:
- Phase 3
SYMPHONY trial of AXS-12 in narcolepsy (1Q 2024)
- Phase 3
ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation (1H
2024)
- Phase 3 FOCUS
trial of solriamfetol in attention deficit hyperactivity disorder
(ADHD) in adults (2H 2024)
-
Clinical Trial Initiations:
- Phase 3 trial
of solriamfetol in major depressive disorder (MDD) (1Q 2024)
- Phase 3 trial
of solriamfetol for binge eating disorder (BED) (1Q 2024)
- Phase 3 trial
of solriamfetol in shift work disorder (SWD) (1Q 2024)
- Pivotal Phase
2/3 trial of AXS-05 for smoking cessation (2024)
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 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 2042.
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 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; differences between the Company’s 2023 preliminary
financial information disclosed herein as compared to the Company’s
final 2023 audited financial statements; delays with respect to the
Company’s 2024 anticipated milestones; 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
Axsome Therapeutics (NASDAQ:AXSM)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Axsome Therapeutics (NASDAQ:AXSM)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024