Phase 4 SPRAVATO® monotherapy data shows rapid
improvement in depressive symptoms at ~24 hours, sustained through
at least 4 weeks
Monotherapy submission builds on more than a decade of
research, 31 clinical trials and more than five years of real-world
use that reinforce the safety and efficacy of
SPRAVATO®
TITUSVILLE, N.J., July 22,
2024 /PRNewswire/ -- Johnson & Johnson (NYSE:
JNJ) announced today the submission of a supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration (FDA)
seeking approval of SPRAVATO® (esketamine) CIII nasal
spray as a monotherapy for adults living with treatment-resistant
depression (TRD). Nearly 30 percent of the estimated 280 million
people worldwide living with major depressive disorder (MDD) have
TRD,1 which occurs when there is an inadequate response
to two or more oral antidepressants during the same depressive
episode.
"Many patients living with challenging-to-treat depression spend
far too long cycling through multiple treatments that don't
effectively resolve their symptoms, which can cause a significant
functional and emotional burden on patients and their loved ones,"
said Bill Martin, PhD, Global
Therapeutic Area Head, Neuroscience, Johnson & Johnson
Innovative Medicine. "We're pleased to build on the more than a
decade of research reinforcing the safety and efficacy of
SPRAVATO® and look forward to working with the FDA to
bring this innovative treatment to patients as a monotherapy
option."
The submission is supported by positive results from the Phase 4
TRD4005 study that evaluated the efficacy, safety and tolerability
of SPRAVATO® administered as a monotherapy. The
randomized, double-blind, multicenter, placebo-controlled study
showed a rapid change in Montgomery-Asberg Depression Rating Scale
(MADRS) total score as early as 24 hours after the first
SPRAVATO® dose and sustained through at least 4 weeks of
treatment. The safety profile of SPRAVATO® monotherapy
was consistent with the existing body of clinical data in
combination with an oral antidepressant, and no new safety concerns
were identified.2
SPRAVATO® is approved by the FDA, in combination with
an oral antidepressant, to treat adults with TRD and depressive
symptoms in adults with MDD with acute suicidal ideation or
behavior. To date, SPRAVATO® has been approved in 77
countries and administered to more than 100,000 people
worldwide.
IMPORTANT SAFETY INFORMATION
What is SPRAVATO® (esketamine) CIII nasal
spray?
SPRAVATO® is a prescription medicine, used along
with an antidepressant taken by mouth to treat:
- Adults with treatment-resistant depression (TRD)
- Depressive symptoms in adults with major depressive disorder
(MDD) with suicidal thoughts or actions
SPRAVATO® is not for use as a medicine to
prevent or relieve pain (anesthetic). It is not known if
SPRAVATO® is safe or effective as an anesthetic
medicine.
It is not known if SPRAVATO® is safe and
effective for use in preventing suicide or in reducing suicidal
thoughts or actions. SPRAVATO® is not for use in
place of hospitalization if your healthcare provider determines
that hospitalization is needed, even if improvement is experienced
after the first dose of SPRAVATO®.
It is not known if SPRAVATO® is safe and
effective in children.
IMPORTANT SAFETY INFORMATION
What is the most
important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side
effects, including:
- Sedation and
dissociation. SPRAVATO® may cause sleepiness
(sedation), fainting, dizziness, spinning sensation, anxiety, or
feeling disconnected from yourself, your thoughts, feelings, space
and time (dissociation).
-
- Tell your healthcare provider right away if
you feel like you cannot stay awake or if you feel like you are
going to pass out.
- Your healthcare provider must monitor you for
serious side effects for at least 2 hours after taking
SPRAVATO®. Your
healthcare provider will decide when you are ready to leave the
healthcare setting.
- Respiratory depression was
observed with the use of SPRAVATO®; additionally, there were rare
reports of respiratory arrest.
o
Your healthcare provider must monitor you for serious side effects
for at least 2 hours (including pulse oximetry) after taking
SPRAVATO®. Your healthcare provider will decide when you
are ready to leave the healthcare setting.
- Abuse and misuse. There is a risk
for abuse and physical and psychological dependence with
SPRAVATO® treatment. Your healthcare
provider should check you for signs of abuse and dependence before
and during treatment with SPRAVATO®.
-
- Tell your healthcare provider if you have
ever abused or been dependent on alcohol, prescription medicines,
or street drugs.
- Your healthcare provider can tell you more
about the differences between physical and psychological dependence
and drug addiction.
- SPRAVATO® Risk Evaluation and
Mitigation Strategy (REMS). Because of the risks for
sedation, dissociation, respiratory depression and abuse and
misuse, SPRAVATO® is only available through a
restricted program called the SPRAVATO® Risk Evaluation and
Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at
healthcare settings certified in the SPRAVATO® REMS Program. Patients
treated in outpatient healthcare settings (e.g., medical offices
and clinics) must be enrolled in the program.
- Increased risk of suicidal thoughts and
actions. Antidepressant medicines may increase suicidal
thoughts and actions in some people 24 years of age and younger,
especially within the first few months of treatment or when the
dose is changed. SPRAVATO® is not for use in
children.
-
- Depression and other serious mental illnesses
are the most important causes of suicidal thoughts and actions.
Some people may have a higher risk of having suicidal thoughts or
actions. These include people who have (or have a family history
of) depression or a history of suicidal thoughts or actions.
- How can I watch for and try to prevent
suicidal thoughts and actions in myself or a family
member?
-
- Pay close attention to any changes,
especially sudden changes, in mood, behavior, thoughts, or
feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if
you have any new or sudden changes in mood, behavior, thoughts, or
feelings.
- Keep all follow-up visits with your
healthcare provider as scheduled. Call your healthcare provider
between visits as needed, especially if you have concerns about
symptoms.
- Tell your healthcare provider right away
if you or your family member have any of the following symptoms,
especially if they are new, worse, or worry you:
-
- Suicide attempts
- Worsening depression
- Thoughts about suicide or dying
- Other unusual changes in behavior or
mood
|
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in
the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries
(arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other
ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions,
talk to your healthcare provider before taking
SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare
provider about all of your medical conditions, including if
you:
- have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest
pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is
increased pressure in the brain
- have liver problems
- have ever had a condition called "psychosis" (see, feel, or
hear things that are not there, or believe in things that are not
true).
- are pregnant or plan to become pregnant.
SPRAVATO® may harm your baby. You should not take
SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant
during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare
provider about methods to prevent pregnancy during treatment
with SPRAVATO®.
- There is a pregnancy registry for women who are exposed
to SPRAVATO® during pregnancy. The purpose of
the registry is to collect information about the health of women
exposed to SPRAVATO® and their baby. If you become
pregnant during treatment with SPRAVATO®, talk to your
healthcare provider about registering with the National Pregnancy
Registry for Antidepressants at 1-844-405-6185 or online
at https://womensmentalhealth.org/clinical-and-research-
programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not
breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that
you take, including prescription and over-the-counter
medicines, vitamins and herbal supplements. Taking
SPRAVATO® with certain medicine may cause side
effects.
Especially tell your healthcare provider if you
take central nervous system (CNS) depressants,
psychostimulants, or monoamine oxidase inhibitors (MAOIs)
medicines. Keep a list of them to show to your healthcare provider
and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself,
under the supervision of a healthcare provider in a healthcare
setting. Your healthcare provider will show you how to use the
SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much
SPRAVATO® you will take and when you will take
it.
- Follow your SPRAVATO® treatment schedule
exactly as your healthcare provider tells you to.
- During and after each use of the
SPRAVATO® nasal spray device, you will be checked
by a healthcare provider who will decide when you are ready to
leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive
you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your
healthcare provider may change your dose and treatment
schedule.
- Some people taking SPRAVATO® get nausea and
vomiting. You should not eat for at least 2 hours before taking
SPRAVATO® and not drink liquids at least 30 minutes
before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant
medicine take these medicines at least 1 hour before taking
SPRAVATO®.
What should I avoid while taking
SPRAVATO®?
Do not drive, operate machinery, or do anything
where you need to be completely alert after taking
SPRAVATO®. Do not take part in these
activities until the next day following a restful sleep.
See "What is the most important information I should know
about SPRAVATO®?"
What are the possible side effects of
SPRAVATO®?
SPRAVATO® may cause serious side effects
including:
See "What is the most important information I should
know about SPRAVATO®?"
Increased blood
pressure. SPRAVATO® can cause a temporary
increase in your blood pressure that may last for about 4 hours
after taking a dose. Your healthcare provider will check your blood
pressure before taking SPRAVATO® and for at least 2
hours after you take SPRAVATO®. Tell your healthcare
provider right away if you get chest pain, shortness of breath,
sudden severe headache, change in vision, or seizures after taking
SPRAVATO®.
Problems with thinking clearly. Tell your healthcare
provider if you have problems thinking or remembering.
Bladder problems. Tell your healthcare provider if
you develop trouble urinating, such as a frequent or urgent need to
urinate, pain when urinating, or urinating frequently at night.
The most common side effects of
SPRAVATO® when used along with an antidepressant
taken by mouth include:
• feeling disconnected
from yourself, your thoughts, feelings and things around
you
• dizziness
• nausea
• feeling
sleepy
• spinning
sensation
|
• decreased feeling of
sensitivity (numbness)
• feeling
anxious
• lack of
energy
• increased blood
pressure
• vomiting
• feeling
drunk
• feeling very happy or
excited
|
If these common side effects occur, they usually happen right
after taking SPRAVATO® and go away the same
day.
These are not all the possible side effects of
SPRAVATO®.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information,
including Boxed WARNINGS, and Medication
Guide for SPRAVATO® and discuss any
questions you may have with your healthcare provider.
cp-170363v3
ABOUT JOHNSON & JOHNSON
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everything. Our strength in healthcare innovation empowers us to
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and where solutions are personal. Through our expertise in
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Learn more at http://www.jnj.com or
at www.janssen.com/johnson-johnson-innovative-medicine. Follow
us at @JNJInnovMed.
Janssen Research & Development, LLC and Janssen Biotech,
Inc. are both Johnson & Johnson companies.
CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development and the potential benefits and
treatment impact of SPRAVATO®. The reader is cautioned
not to rely on these forward-looking statements. These statements
are based on current expectations of future events. If underlying
assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially
from the expectations and projections of Janssen Research &
Development, LLC, Janssen Biotech, Inc., and/or Johnson &
Johnson. Risks and uncertainties include, but are not limited to:
challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products, and patents attained by
competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of healthcare
products and services; changes to applicable laws and regulations,
including global healthcare reforms; and trends toward healthcare
cost containment. A further list and descriptions of these risks,
uncertainties, and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
December 31, 2023, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in Johnson &
Johnson's subsequent Quarterly Reports on Form 10-Q and other
filings with the U.S. Securities and Exchange Commission. Copies of
these filings are available online at www.sec.gov, www.jnj.com, or
on request from Johnson & Johnson. None of Janssen Research
& Development, LLC, Janssen Biotech, Inc. nor Johnson &
Johnson undertakes to update any forward-looking statement as a
result of new information or future events or developments.
© Johnson & Johnson 2024. All rights reserved.
Media contact:
Caitlin
Lormel
Johnson & Johnson
clormel@its.jnj.com
732 740 1701
Investor contact:
Raychel
Kruper
Johnson & Johnson
investor-relations@its.jnj.com
- Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and
national burden of treatment-resistant depression and major
depressive disorder in the United
States. J Clin Psychiatry. 2021;82(2):20m13699.
- A. Janik, X. Qiu, R. Lane, V. Popova, W.C. Drevets, C. Canuso,
D.J. Fu. SPRAVATO (Esketamine Nasal Spray) as a Monotherapy for
Treatment-resistant Depression (TRD). American Society of
Psychopharmacology Annual Meeting.; May
28-31, 2024. Poster W80.
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