ZURZUVAE™ (zuranolone) approved as
first-and-only oral treatment specifically indicated for adults
with postpartum depression (PPD) and on-track for planned launch in
the fourth quarter of 2023 shortly after DEA scheduling
Sage brain health pipeline provides potential
for significant long-term value creation
Remain well capitalized with $1.0 billion of
cash, cash equivalents and marketable securities as of June 30,
2023
Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical
company leading the way to create a world with better brain health,
today reported business highlights and financial results for the
second quarter ended June 30, 2023.
“We are currently at a tipping point with the burden and
prevalence of brain health conditions accelerating at an alarming
rate. The need has never been greater than it is today and our team
is singularly focused on changing the trajectory of these
devastating diseases through our development efforts and novel
pipeline,” said Barry Greene, Chief Executive Officer at Sage
Therapeutics. “We were delighted to receive U.S. Food and Drug
Administration (FDA) approval for ZURZUVAE as the first-and-only
oral treatment specifically indicated for adults with postpartum
depression (PPD), the most common medical complication of
childbirth. We believe the need for new treatment options for women
with PPD is a significant medical need and presents a strong
business opportunity. While we were very disappointed by the recent
Complete Response Letter (CRL) we received from the FDA regarding
zuranolone in the treatment of major depressive disorder (MDD), we
are reviewing the feedback from the FDA and evaluating next
steps.”
“While we believe we are well capitalized, given the impact of
the CRL for zuranolone in MDD on our plans, we are currently
evaluating resource allocation, including pipeline prioritization
and a workforce reorganization with a goal of extending our cash
runway. With a right-sized organization and portfolio, we believe
we have an opportunity to emerge as an even stronger company. We
plan to provide greater detail and next steps before the end of the
third quarter,” continued Mr. Greene.
Second Quarter 2023 Portfolio
Updates
Sage is advancing a portfolio of clinical-stage programs with
internally discovered novel chemical entities that have the
potential to address urgent unmet needs in brain health by
targeting the GABAA and NMDA receptor systems. Dysfunction in these
systems is thought to be at the core of numerous neurological and
neuropsychiatric disorders.
Depression Franchise
ZURZUVAE was approved by the FDA in August 2023 as the
first-and-only oral treatment specifically indicated for adults
with PPD. Zuranolone is a next-generation positive allosteric
modulator (PAM) of GABAA receptors being evaluated as a treatment
for various affective disorders in collaboration with Biogen Inc.
Sage also commercializes ZULRESSO® (brexanolone) CIV injection in
the treatment of PPD.
ZURZUVAE is expected to be commercially available for adults
with PPD in the fourth quarter of 2023 shortly following scheduling
by the U.S. Drug Enforcement Administration (DEA), which is
expected to occur within 90 days.
Sage also announced that the FDA issued a CRL for the New Drug
Application (NDA) seeking approval of zuranolone as a treatment for
MDD.
In the CRL, the FDA stated that the application did not provide
substantial evidence of effectiveness to support the approval of
zuranolone for the treatment of MDD and that an additional study or
studies will be needed. Sage and Biogen are reviewing the feedback
from the FDA and are evaluating next steps.
Today, Sage also announced additional data from the open-label
SHORELINE Study in MDD, specifically from the cohort of patients
(n=277) that rolled over into the SHORELINE Study from the CORAL
Study. In this cohort, the adverse event profile and the data
generated on repeat treatments were similar to previously reported
data from other cohorts of the SHORELINE Study, with no new safety
signals identified. Sage plans to present further analyses from the
SHORELINE Study at future medical congresses.
The Company expects the following milestones in its Depression
franchise in late 2023:
- Commercial availability of ZURZUVAE in the treatment of adults
with PPD in the fourth quarter of 2023 shortly following DEA
scheduling
- Present additional analyses of data from LANDSCAPE and NEST
clinical programs, including health economics and patient reported
outcomes
Neuropsychiatry Franchise
SAGE-718, the Company’s first-in-class NMDA receptor PAM and
lead neuropsychiatric drug candidate, is in development as a
potential oral therapy for cognitive disorders associated with NMDA
receptor dysfunction, including Huntington’s disease (HD),
Parkinson’s disease (PD) and Alzheimer’s disease (AD). SAGE-718 has
received Fast Track Designation from the FDA and Orphan Drug
Designation from the European Medicines Agency (EMA) for the
potential treatment of HD.
Sage is advancing a robust clinical program for SAGE-718 and is
currently enrolling in the following studies with data read-outs
expected to begin in 2024:
- DIMENSION (CIH-201) Study: The
DIMENSION Study is a double-blind, placebo-controlled Phase 2 study
in people with HD cognitive impairment. The study is designed to
evaluate the efficacy of once-daily SAGE-718 dosed over three
months, with a target enrollment of approximately 178 people. Sage
expects the DIMENSION Study to include more than 40 clinical
sites.
- SURVEYOR (CIH-202) Study: The
SURVEYOR Study is a double-blind, placebo-controlled Phase 2 study
in people with HD cognitive impairment and healthy volunteers, with
the goal of generating evidence linking efficacy signals on
cognitive performance to domains of real-world functioning.
- PURVIEW (CIH-301) Study: The
PURVIEW Study is an open-label Phase 3 safety study of SAGE-718 in
people with HD cognitive impairment. The study is designed to
evaluate the long-term safety profile and benchmark performance
against HD natural history studies.
- PRECEDENT (CNP-202) Study: The
PRECEDENT Study is a double-blind, placebo-controlled Phase 2 study
in people with mild cognitive impairment due to PD. The study is
designed to evaluate the safety and efficacy of SAGE-718 dosed over
42 days, followed by a controlled follow-up period.
- LIGHTWAVE (can-202) Study: The
LIGHTWAVE Study is a double-blind, placebo-controlled Phase 2 study
of SAGE-718 in people with MCI and mild dementia due to AD. The
study is designed to evaluate the safety and efficacy of SAGE-718
dosed over an 84-day period, followed by a controlled follow-up
period.
The Company expects the following milestones in neuropsychiatry
in 2023:
- Progress recruitment in the ongoing DIMENSION, SURVEYOR,
PURVIEW, PRECEDENT, and LIGHTWAVE Studies
- Present additional analyses of data on disease state and burden
of disease research in Huntington’s, Parkinson’s and Alzheimer’s
diseases
Neurology Franchise
Sage’s lead neurology drug candidates include SAGE-324 and
SAGE-689. SAGE-324, a next-generation PAM of GABAA receptors and
Sage’s lead neurology program, is in development as a potential
oral therapy for movement disorders, such as essential tremor (ET),
epilepsy and PD. SAGE-689, a Sage wholly-owned program, is an
intramuscular balanced GABAA receptor PAM in development as a
potential therapy for disorders associated with GABA
hypofunction.
Sage and its collaborator, Biogen, are actively enrolling
participants in the Phase 2b KINETIC 2 placebo-controlled study of
SAGE-324 in ET following positive results from the KINETIC Study.
The KINETIC 2 Study is a Phase 2b dose-ranging study with the
primary goal of defining the dose for SAGE-324 in ET with a good
tolerability profile and a dosing schedule to maintain plasma
concentrations needed for sustained tremor symptom control in
treating ET. Enrollment in the KINETIC 2 Study is targeted for
completion in late 2023.
Sage is also currently enrolling patients in a Phase 2 long-term
open label safety study, to evaluate the long-term safety and
tolerability of SAGE-324 in ET. The primary endpoint of the
open-label study is incidence of treatment-emergent adverse
events.
SAGE-689 continues in Phase 1 development.
The Company expects the following milestones in neurology in
2023:
Late 2023:
- Targeted completion of enrollment in the Phase 2b KINETIC 2
Study
- Present additional analyses of data from clinical development
program as well as disease state and burden of disease research in
ET
Early Development
Sage continues to progress its early development programs,
SAGE-319 and SAGE-421. SAGE-319 is currently in Phase 1 studies and
IND-enabling work is underway for SAGE-421.
- SAGE-319: an oral, extra-synaptic preferring GABAA
receptor PAM that Sage plans to study for potential use in
disorders of social interaction.
- SAGE-421: an oral, NMDA receptor PAM that Sage plans to
study for potential use in neurodevelopmental disorders and
cognitive recovery and rehabilitation.
FINANCIAL RESULTS FOR THE SECOND
QUARTER 2023
- Cash Position: Cash, cash equivalents and marketable
securities as of June 30, 2023, were $1.0 billion compared to $1.1
billion at March 31, 2023.
- Revenue: Net revenue from sales of ZULRESSO was $2.5
million in the second quarter of 2023 compared to $1.5 million in
the same period of 2022.
- R&D Expenses: Research and development expenses were
$97.2 million, including $4.5 million of non-cash stock-based
compensation expense, in the second quarter of 2023 compared to
$77.3 million, including $6.5 million of non-cash stock-based
compensation expense, in the same period of 2022. The increase in
spending was primarily due to an increase in the hiring of
employees and corporate infrastructure costs, such as information
technology costs, to support the growth in our research and
development operations. The reimbursement from Biogen to Sage for
R&D expenses pursuant to the Sage/Biogen Collaboration and
License Agreement was $22.4 million in the second quarter of 2023
compared to $21.0 million in the same period of 2022.
- SG&A Expenses: Selling, general and administrative
expenses were $75.6 million, including $7.2 million of non-cash
stock-based compensation expense, in the second quarter of 2023
compared to $52.4 million, including $8.2 million of non-cash
stock-based compensation expense, in the same period of 2022. The
increase in SG&A expenses was primarily due to hiring employees
to support ongoing activities in anticipation of the potential
launch of zuranolone. The reimbursement from Sage to Biogen for
SG&A expenses pursuant to the Sage/Biogen Collaboration and
License Agreement was $7.5 million in the second quarter of 2023
compared to $2.8 million of reimbursement from Biogen to Sage in
the same period of 2022. The primary reason for the decrease in net
reimbursement was an increase in the collaboration costs incurred
by Biogen in anticipation of a potential commercialization of
zuranolone.
- Net Loss: Net loss was $160.3 million in the second
quarter of 2023 compared to $126.3 million in the same period of
2022.
FINANCIAL GUIDANCE
- Based upon Sage’s current estimates, Sage expects that its
current cash, cash equivalents and marketable securities, along
with anticipated funding from ongoing collaborations and potential
revenue, will support its operations into 2025.
- Additionally, Sage is evaluating resource allocation, including
pipeline prioritization and a workforce reorganization, with a goal
of extending its cash runway and anticipates operating expenses
will decrease in 2024.
- We have the potential to earn a milestone payment of $75.0
million from Biogen related to the first commercial sale of
ZURZUVAE for the treatment of PPD.
About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical company fearlessly
leading the way to create a world with better brain health. Our
mission is to pioneer solutions to deliver life-changing brain
health medicines, so every person can thrive. For more information,
please visit http://www.sagerx.com.
Forward-Looking Statements
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation our
statements regarding: the completion of DEA scheduling, plans for
launch, availability and commercialization of ZURZUVAE as a
treatment for women with PPD, and potential timing of such
activities; our belief in the business case in PPD and our
readiness for commercial launch of ZURZUVAE in this indication; our
plans to review the CRL received with respect to zuranolone for the
treatment of MDD and evaluation of next steps; the potential
benefit of ZURZUVAE in the treatment of women with PPD; the number
of women with PPD and the potential market for ZURZUVAE for the
treatment of women with PPD; our belief in the potential of
ZURZUVAE to be successful and to meet an unmet need in the
treatment of women with PPD, anticipated timelines for commencement
of trials, completion of enrollment, initiation of new activities
and other plans for our other programs and early stage pipeline;
our belief in the potential profile and benefit of our product
candidates; potential indications for our product candidates; the
potential for success of our programs, and the opportunity to help
patients in various indications; the potential for value creation
opportunities; the mission and goals for our business; our
anticipated cash runway and plans to evaluate resource allocation
and a reorganization with a goal of extending the cash runway and
becoming a stronger company; and our expectations with respect to
potential receipt of milestones from collaborations, potential
future revenue, funding of future operations, and a potential
decrease in expenses. These statements constitute forward-looking
statements as that term is defined in the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
neither promises nor guarantees of future performance, and are
subject to a variety of risks and uncertainties, many of which are
beyond our control, which could cause actual results to differ
materially from those contemplated in these forward-looking
statements, including the risks that: our launch and
commercialization efforts in the U.S. with respect to ZURZUVAE for
the treatment of women with PPD may not be successful, and we may
be unable to generate revenues at the levels or on the timing we
expect or at levels or on the timing necessary to support our
goals; the number of patients with the diseases or disorders for
which our products are developed and approved, the unmet need for
additional treatment options, and the potential market for ZURZUVAE
in women with PPD, or for any other future products, if
successfully developed, may be significantly smaller than we
expect; ZURZUVAE or any other products that we may successfully
develop in the future, may not achieve the clinical benefit,
clinical use or market acceptance we expect or we may encounter
reimbursement-related or other market-related issues that impact
the success of our commercialization efforts; we may never achieve
regulatory approval for zuranolone in MDD; the FDA has taken the
position that one or more additional clinical trials of zuranolone
are required to support approval in MDD, and even if we appeal this
decision in the future, the FDA may not change that position; such
trial or trials could be time-consuming, significantly increase our
expenses, and may not be feasible; even if we conduct such clinical
trials, they may not be successful; the FDA may decide that the
design, conduct or results of our clinical trials for zuranolone,
even if positive, are not sufficient for approval in MDD or may
find other deficiencies in our development program, data,
processes, or manufacturing sites; even if we receive regulatory
approval of zuranolone for the treatment of MDD, the FDA may
approve zuranolone for only a subset of MDD patients or with
limitations or restrictions; even if we run additional clinical
trials to try to obtain approval of zuranolone in MDD or with
respect to clinical trials for our other product candidates, we may
encounter delays in initiation, conduct, completion of enrollment
or completion of any such clinical trials, including as a result of
slower than expected site initiation, slower than expected
enrollment, the need or decision to expand the trials or other
changes, that may impact our ability to meet our expected timelines
and may increase our costs; success in earlier clinical trials of
zuranolone or any of our product candidates may not be repeated or
observed in ongoing or future studies, and ongoing and future
clinical trials may not meet their primary or key secondary
endpoints which may substantially impair development; unexpected
concerns may arise from additional data, analysis or results from
any of our completed studies; decisions or actions of the FDA may
affect the initiation, timing, design, size, progress and cost of
clinical trials and our ability to proceed with further development
or may impair the potential for successful development; the need to
align with our collaborators may hamper or delay our development
and commercialization efforts or increase our costs; the
anticipated benefits of our ongoing collaborations, including the
receipt of milestone payments or the successful development or
commercialization of products and generation of revenue, may never
be achieved; our business may be adversely affected and our costs
may increase if any of our key collaborators fails to perform its
obligations or terminates our collaboration; and the internal and
external costs required for our ongoing and planned activities, and
the resulting impact on expense and use of cash, may be higher than
expected which may cause us to use cash more quickly than we expect
or to change or curtail some of our plans or both; the internal and
external costs required for our ongoing and planned activities, and
the resulting impact on expense and use of cash, may be higher than
expected, and our plans to evaluate resource allocation with the
goal of extending our cash runway may not be successful or actually
extend our cash runway; we may never be able to generate meaningful
revenues from sales of ZULRESSO or to generate revenues at levels
we expect or at levels necessary to justify our investment; we may
not be successful in our efforts to gain regulatory approval of
products beyond ZURZUVAE and ZULRESSO; we may not achieve revenues
from other of our products that may be successfully developed in
the future, at levels we expect; our expectations as to cash
runway, the sufficiency of cash to fund future operations and
expense levels may prove not to be correct for these and other
reasons such as changes in plans or actual events being different
than our assumptions; we may be opportunistic in our future
financing plans even if available cash is sufficient; additional
funding may not be available on acceptable terms when we need it;
and we may encounter technical and other unexpected hurdles in the
development and manufacture of our product candidates or the
commercialization of any current or future marketed product which
may delay our timing or change our plans, increase our costs or
otherwise negatively impact our business; as well as those risks
more fully discussed in the section entitled "Risk Factors" in our
most recent quarterly report, as well as discussions of potential
risks, uncertainties, and other important factors in our subsequent
filings with the Securities and Exchange Commission. In addition,
any forward-looking statements represent our views only as of today
and should not be relied upon as representing our views as of any
subsequent date. We explicitly disclaim any obligation to update
any forward-looking statements.
Financial Tables
Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Balance Sheets (in thousands) (unaudited)
June 30,2023 December 31,2022 Cash, cash equivalents
and marketable securities
$
1,002,616
$
1,272,494
Total assets
1,082,288
1,356,449
Total liabilities
97,912
103,850
Total stockholders' equity
984,376
1,252,599
Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Statements of Operations (in thousands, except
share and per share data) (unaudited)
Three Months Ended
June 30, Six Months Ended June 30,
2023
2022
2023
2022
Product revenue, net
$
2,460
$
1,501
$
5,754
$
3,082
Collaboration revenue
14
-
14
-
Total revenue
2,474
1,501
5,768
3,082
Operating costs and expenses: Cost of goods sold
205
200
435
486
Research and development
97,161
77,297
189,987
155,315
Selling, general and administrative
75,565
52,411
141,273
98,888
Total operating costs and expenses
172,931
129,908
331,695
254,689
Loss from operations
(170,457
)
(128,407
)
(325,927
)
(251,607
)
Interest income, net
10,173
2,102
19,003
3,270
Other income (expense), net
(41
)
45
(229
)
22
Net loss
$
(160,325
)
$
(126,260
)
$
(307,153
)
$
(248,315
)
Net loss per share - basic and diluted
$
(2.68
)
$
(2.13
)
$
(5.14
)
$
(4.20
)
Weighted average shares outstanding - basic and diluted
59,769,640
59,266,322
59,722,147
59,148,246
ZURZUVAE (zuranolone) IMPORTANT SAFETY
INFORMATION
What is the most important information I should know about
ZURZUVAE?
ZURZUVAE may cause serious side effects, including:
- Decreased ability to drive or do other dangerous
activities. ZURZUVAE may decrease your awareness and alertness,
which can affect your ability to drive safely or safely do other
dangerous activities.
- Do not drive, operate machinery, or do other dangerous
activities until at least 12 hours after taking each
dose during your 14-day treatment course of ZURZUVAE.
- You may not be able to tell on your own if you can drive safely
or tell how much ZURZUVAE is affecting you.
- Decreased awareness and alertness [central nervous system
(CNS) depressant effects]. ZURZUVAE may cause sleepiness,
drowsiness, slow thinking, dizziness, confusion, and trouble
walking.
- Because of these symptoms, you may be at a higher risk for
falls during treatment with ZURZUVAE.
- Taking alcohol, other medicines that cause CNS depressant
effects, or opioids while taking ZURZUVAE can make these symptoms
worse and may also cause trouble breathing.
- Tell your healthcare provider if you develop any of these
symptoms, or if they get worse during treatment with ZURZUVAE. Your
healthcare provider may decrease your dose or stop ZURZUVAE
treatment if you develop these symptoms.
ZURZUVAE is a federally controlled substance (C-XX) because it
contains zuranolone that can be abused or lead to dependence. Keep
ZURZUVAE in a safe place to protect it from theft. Do not sell or
give away ZURZUVAE because it may harm others and is against the
law.
Before taking ZURZUVAE, tell your healthcare provider about
all of your medical conditions, including if you:
- drink alcohol
- have abused or been dependent on prescription medicines, street
drugs, or alcohol
- have liver or kidney problems
- are pregnant or plan to become pregnant. ZURZUVAE may harm your
unborn baby.
- are breastfeeding or plan to breastfeed. ZURZUVAE passes into
breast milk, and it is not known if it can harm your baby. Talk to
your healthcare provider about the risks and benefits of
breastfeeding and about the best way to feed your baby during
treatment with ZURZUVAE.
Females who are able to become pregnant:
- Tell your healthcare provider right away if you become pregnant
during treatment with ZURZUVAE.
- You should use effective birth control (contraception) during
treatment with ZURZUVAE and for 1 week after the final dose.
- There is a pregnancy registry for females who are exposed to
ZURZUVAE during pregnancy. The purpose of the registry is to
collect information about the health of females exposed to ZURZUVAE
and their baby. If you become pregnant during treatment with
ZURZUVAE, talk to your healthcare provider about registering with
the National Pregnancy Registry for Antidepressants at
1-844-405-6185 or visit online at
https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. ZURZUVAE and some medicines may
interact with each other and cause serious side effects. ZURZUVAE
may affect the way other medicines work and other medicines may
affect the way ZURZUVAE works.
Especially tell your healthcare provider if you take
antidepressants, opioids, or CNS depressants such as
benzodiazepines.
What should I avoid while taking ZURZUVAE?
- Do not drive a car, operate machinery, or do other
dangerous activities until at least 12 hours after taking each
dose of ZURZUVAE because ZURZUVAE may make you feel sleepy,
confused, or dizzy.
- Do not drink alcohol or take other medicines that make
you sleepy or dizzy while taking ZURZUVAE without talking to your
healthcare provider.
See “What is the most important information I should know
about ZURZUVAE?”
ZURZUVAE may cause serious side effects, including:
- See “What is the most important information I should know
about ZURZUVAE?”
- Increased risk of suicidal thoughts or actions. ZURZUVAE
and other antidepressant medicines may increase the risk of
suicidal thoughts and actions in people 24 years of age and
younger. ZURZUVAE is not for use in children.
How can I watch for and try to prevent suicidal thoughts and
actions?
- Pay close attention to any changes, especially sudden changes
in mood, behavior, thoughts, or feelings, or if you develop
suicidal thoughts or actions. This is very important when an
antidepressant medicine is started or when the dose is
changed.
- 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 have any of
the following symptoms, especially if they are new, worse, or worry
you:
- attempts to commit suicide
- thoughts about suicide or dying
- new or worse depression
- feeling very agitated or restless
- trouble sleeping (insomnia)
- new or worse anxiety
- panic attacks
- new or worse irritability
- acting aggressive, being angry, or violent
- an extreme increase in activity and talking (mania)
- acting on dangerous impulses
- other unusual changes in behavior or mood
The most common side effects of ZURZUVAE include:
- Sleepiness or drowsiness, dizziness, common cold, diarrhea,
feeling tired, weak, or having no energy, and urinary tract
infection
These are not all of the possible side effects of ZURZUVAE. Call
your doctor for medical advice about side effects. You can report
side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the Full Prescribing Information,
including Boxed WARNING, and Medication Guide for
ZURZUVAE.
ZULRESSO (brexanolone) SELECT IMPORTANT
SAFETY INFORMATION
This does not include all the information needed to use ZULRESSO
safely and effectively. See full prescribing information for
ZULRESSO.
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF
CONSCIOUSNESS
See full prescribing information for complete boxed warning
Patients are at risk of excessive sedation or sudden loss of
consciousness during administration of ZULRESSO.
Because of the risk of serious harm, patients must be
monitored for excessive sedation and sudden loss of consciousness
and have continuous pulse oximetry monitoring. Patients must be
accompanied during interactions with their child(ren).
ZULRESSO is available only through a restricted program
called the ZULRESSO REMS.
WARNINGS AND PRECAUTIONS
Suicidal Thoughts and Behaviors: Consider changing the
therapeutic regimen, including discontinuing ZULRESSO, in patients
whose PPD becomes worse or who experience emergent suicidal
thoughts and behavior.
ADVERSE REACTIONS: Most common adverse reactions
(incidence ≥5% and at least twice the rate of placebo) were
sedation/somnolence, dry mouth, loss of consciousness, and
flushing/hot flush.
USE IN SPECIFIC POPULATIONS
- Pregnancy: ZULRESSO may cause fetal harm. Healthcare
providers are encouraged to register patients by calling the
National Pregnancy Registry for Antidepressants at 1-844-405-6185
or visiting online at
https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/
- Renal Impairment: Avoid use of ZULRESSO in patients with
end stage renal disease (ESRD)
Controlled Substance: ZULRESSO contains brexanolone, a
Schedule IV controlled substance under the Controlled Substances
Act.
To report SUSPECTED ADVERSE REACTIONS, contact Sage
Therapeutics, Inc. at 1-844-4-SAGERX (1-844-472-4379) or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Please see accompanying full Prescribing Information
including Boxed Warning.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230806319678/en/
Investor Ashley Kaplowitz 786-252-1419
ashley.kaplowitz@sagerx.com
Media Matthew Henson 917-930-7147
matthew.henson@sagerx.com
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