ZURZUVAE™ (zuranolone), the first-and-only oral
treatment indicated for adults with postpartum depression (PPD),
became commercially available mid-December; Sage achieved $0.8
million in collaboration revenue as of December 31, 2023, 50% of
the net revenues Biogen reports for ZURZUVAE
Encouraging early launch results for ZURZUVAE
with approximately 120 prescriptions in December
Catalyst rich 2024 with multiple topline data
read-outs expected across dalzanemdor (SAGE-718) and SAGE-324 with
potential for significant long-term value creation
Strong financial foundation with year-end 2023
cash, cash equivalents and marketable securities of $753
million
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
fourth quarter and full year ended December 31, 2023.
“2023 was a pivotal year for Sage, with key accomplishments
achieved across our pipeline, culminating with the recent
encouraging launch of ZURZUVAE, the first-and-only once daily oral
treatment for adults with postpartum depression. We are incredibly
pleased with the early progress on the launch. I am proud of our
team’s relentless work toward our goal of ZURZUVAE becoming the
first line therapy for women with PPD and believe strongly in the
potential for ZURZUVAE to make an impact in treating this
devastating disease,” said Barry Greene, Chief Executive Officer at
Sage Therapeutics. “Beyond our ongoing commercialization efforts
for ZURZUVAE, we look forward to delivering on multiple anticipated
catalysts in 2024, including topline data from our studies
evaluating dalzanemdor and SAGE-324. We believe our work has the
potential to make a difference in the lives of patients with brain
health disorders, and we look forward to providing updates on our
progress over the coming quarters.”
Key 2023 Highlights
U.S. Food and Drug Administration (FDA) Approval of ZURZUVAE
(zuranolone) for the treatment of adults with PPD: In December
2023, Sage and its collaborator, Biogen, announced the commercial
availability of ZURZUVAE indicated for the treatment of adults with
PPD following its approval by the FDA in August 2023. Efforts to
establish ZURZUVAE as the first line therapy and standard of care
for women with PPD are underway.
- In November 2023, ZURZUVAE received a Schedule IV
classification from the U.S. Drug Enforcement Administration (DEA).
Schedule IV drugs, substances or chemicals are defined as drugs
with a low potential for abuse and low risk of dependence.
Continued advancement across innovative brain health pipeline
with potential for significant long-term value creation: Sage
continued to progress enrollment across multiple Phase 2 studies in
its clinical-stage pipeline which includes dalzanemdor (SAGE-718)
and SAGE-324.
- Dalzanemdor (SAGE-718):
- Sage completed enrollment in the Phase 2 PRECEDENT
placebo-controlled study of dalzanemdor in people with mild
cognitive impairment due to Parkinson’s Disease. Topline data from
the study are expected in early 2024.
- The United States Adopted Name (USAN) Council assigned the
nonproprietary name of “dalzanemdor” to investigational
SAGE-718.
- Dalzanemdor was granted Orphan Drug Designation for the
treatment of Huntington’s Disease by the FDA and by the European
Medicines Agency (EMA).
- SAGE-324:
- In December 2023, Sage and its collaborator, Biogen, completed
screening in the Phase 2b KINETIC 2 placebo-controlled study of
SAGE-324 in essential tremor. In January 2024, the study completed
enrollment. Topline data are expected in mid-2024.
Fourth Quarter 2023 Portfolio
Updates
Sage is advancing a portfolio of clinical-stage programs
featuring internally discovered novel chemical entities with the
potential to become differentiated products designed to improve
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.
Postpartum Depression Commercial Products
ZURZUVAE was approved by the FDA in August 2023 as the
first-and-only oral treatment specifically indicated for adults
with PPD. ZURZUVAE was made commercially available in December
2023. ZURZUVAE is being developed and commercialized in
collaboration with Biogen Inc. Sage also commercializes ZULRESSO®
(brexanolone) CIV injection in the treatment of PPD.
ZURZUVAE
Sage and its collaborator, Biogen, are focused on the goal of
establishing ZURZUVAE as the first line therapy and standard of
care for women with PPD. ZURZUVAE was made commercially available
in December 2023. The companies are utilizing a specialty pharmacy
distribution model by which ZURZUVAE is shipped directly to women
with PPD who are prescribed the treatment.
Initial launch data reflects demand from an estimated 10 days
when patients could access health care professional (HCP) offices.
As of December 31, 2023, the following results had been
achieved:
- $0.8 million in collaboration revenue from ZURZUVAE,
representing 50% of the net revenues recorded when Biogen shipped
ZURZUVAE to the distributors. ZURZUVAE net revenues in December
2023 principally represent initial efforts of preparing the channel
for the full launch in the first quarter of 2024.
- Approximately 120 prescriptions written by various physician
types, including psychiatrists, OBGYNs, and primary care physicians
(PCPs).
- In December, 50 prescriptions shipped and were delivered.
Sage and Biogen field sales teams are engaging in promotional
dialogues with HCPs who actively identify and treat women with PPD.
In December, prescriptions were primarily written by OBGYNs and
psychiatrists, who prescribed in approximately equal numbers. There
were also a small number of prescriptions from PCPs.
The companies are advancing discussions with national, regional
and government payors to advocate for broad and equitable access to
ZURZUVAE for women with PPD with minimal restrictions and expect
formulary discussions to continue over the course of 2024. In the
early launch, the vast majority of prescriptions were covered by
payers.
At commercial availability, Sage and Biogen launched a patient
support program, ZURZUVAE For You, which provides educational
resources, help with understanding insurance coverage, and
assistance navigating the prescription fulfillment process. The
program also includes financial assistance, such as a copay
assistance program and product at no cost, for eligible patients.
In December, the commercially insured patients using the ZURZUVAE
savings card paid no copay.
The Company expects the following milestones for ZURZUVAE in
2024:
- Early 2024:
- Broader complement of capabilities for commercializing ZURZUVAE
in the treatment of women with PPD
- 2024:
- Present additional analyses of data from NEST clinical program,
including health economics and patient reported outcomes
Pipeline
Dalzanemdor (SAGE-718), the Company’s first-in-class NMDA
receptor positive allosteric modulator (PAM), is in development as
a potential oral therapy for cognitive impairment associated with
neurodegenerative disorders. Dalzanemdor has received Fast Track
Designation and Orphan Drug Designation (ODD) from the FDA, and
Orphan Drug Designation from the European Medicines Agency (EMA)
for the potential treatment of Huntington’s Disease. Dalzanemdor
has also been awarded an Innovation Passport Designation for
cognitive impairment associated with HD and entry into the
Innovative Licensing and Access Pathway (ILAP) by the U.K.
Medicines and Healthcare products Regulatory Agency (MHRA).
SAGE-324, the Company’s next-generation PAM of GABAA receptors, is
in development as a potential oral therapy for movement disorders,
such as essential tremor (ET). SAGE-324 is being developed in
collaboration with Biogen Inc.
Dalzanemdor (SAGE-718)
Sage is advancing a robust clinical program for dalzanemdor with
multiple ongoing Phase 2 studies, including the DIMENSION and
SURVEYOR Studies in people with cognitive impairment associated
with Huntington’s Disease (HD), the lead indication for
dalzanemdor, the PRECEDENT Study in people with mild cognitive
impairment (MCI) associated with Parkinson’s Disease (PD) and the
LIGHTWAVE Study in people with MCI and mild dementia due to
Alzheimer’s Disease (AD).
In January 2024, the ILAP Steering Group awarded an Innovative
Passport Designation to dalzanemdor for cognitive impairment
associated with HD. Innovation Passport Designation supports
enhanced coordination of development activities, including access
to a range of development tools and other potential benefits.
Eligibility for the designation is based on a set of criteria
including the potential to treat a life-threatening or serious
condition for which there is significant unmet need. ILAP does not
necessarily lead to a faster development pathway or regulatory
review process and does not increase the likelihood of regulatory
approval.
Ongoing studies in the dalzanemdor clinical program include:
- DIMENSION (CIH-201) Study: The
DIMENSION Study is a double-blind, placebo-controlled Phase 2 study
in people with cognitive impairment associated with HD. The study
is designed to evaluate the efficacy of once-daily dalzanemdor
dosed over three months, with a target enrollment of approximately
178 people. The DIMENSION Study is enrolling across 40 clinical
sites.
- SURVEYOR (CIH-202) Study: The
SURVEYOR Study is a double-blind, placebo-controlled Phase 2 study
in people with cognitive impairment associated with HD. The
SURVEYOR Study is being conducted with the goal of generating
evidence linking changes in cognition to real-world functioning and
is not designed or powered to demonstrate a statistically
significant difference between dalzanemdor and placebo.
- PURVIEW (CIH-301) Study: The
PURVIEW Study is an open-label Phase 3 safety study of dalzanemdor
in people with cognitive impairment associated with HD. The study
is designed to evaluate the long-term safety profile and long-term
functioning compared to HD natural history studies of those treated
for one year or more.
- PRECEDENT (CNP-202) Study: The
PRECEDENT Study is a double-blind, placebo-controlled Phase 2 study
in people with MCI due to PD. The study is designed to evaluate the
safety and efficacy of dalzanemdor dosed over 6 weeks.
- LIGHTWAVE (CNA-202) Study: The
LIGHTWAVE Study is a double-blind, placebo-controlled Phase 2 study
of dalzanemdor in people with MCI and mild dementia due to AD. The
study is designed to evaluate the safety and efficacy of
dalzanemdor dosed over a 12-week period.
The Company expects the following milestones for dalzanemdor in
2024:
- Early 2024:
- Report topline data from PRECEDENT Study in people with MCI
associated with PD
- Mid-2024:
- Report topline data from SURVEYOR Study in people with HD
cognitive impairment
- Late 2024:
- Report topline data from LIGHTWAVE Study in people with MCI and
mild dementia due to AD
- Report topline data from DIMENSION Study in people with HD
cognitive impairment
- 2024:
- Present additional analyses of data from clinical development
program as well as disease state and burden of disease research in
HD, PD and/or AD
SAGE-324
Sage and its collaborator, Biogen, have completed enrollment in
the Phase 2b KINETIC 2 placebo-controlled study of SAGE-324 in ET,
which follows positive results from the completed KINETIC Study of
SAGE-324 in ET. KINETIC 2 is a Phase 2b dose-ranging study with the
primary goal of defining the dose for SAGE-324 with an efficacy and
tolerability profile that maintains plasma concentrations needed
for sustained tremor symptom control in treating ET. Topline data
from the KINETIC 2 Study are expected in mid-2024.
Sage is also 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 is incidence
of treatment-emergent adverse events.
The Company expects the following milestones for SAGE-324 in
2024:
- Mid-2024:
- Report topline data from Phase 2b KINETIC 2 Study in people
with ET
- 2024:
- Present additional analyses of data from clinical development
program as well as disease state and burden of disease research in
ET
FINANCIAL RESULTS FOR THE FOURTH
QUARTER AND FULL YEAR 2023
- Cash Position: Cash, cash equivalents and marketable
securities as of December 31, 2023 were $753 million compared to
$876 million at September 30, 2023.
- Revenue: Collaboration revenue from sales of ZURZUVAE
was $0.8 million in the fourth quarter of 2023, the first quarter
of sales. Reported collaboration revenue is 50% of the net revenues
Biogen reports for ZURZUVAE. ZURZUVAE net revenues in December 2023
principally represent initial efforts of preparing the channel for
the full launch in the first quarter of 2024. License and milestone
revenue was $75.0 million in the fourth quarter of 2023 and for the
year ended December 31, 2023, compared to no such revenues in the
same periods of 2022. The $75.0 million milestone payment was
earned in the fourth quarter of 2023 upon the first commercial sale
of ZURZUVAE in PPD and was received from Biogen in January 2024.
Net revenue from sales of ZULRESSO was $2.0 million in the fourth
quarter of 2023, compared to $2.9 million in the same period of
2022. For the year ended December 31, 2023, net revenue from sales
of ZULRESSO was $10.5 million compared to $7.7 million in the same
period of 2022.
- R&D Expenses: Research and development expenses were
$64.3 million, including $4.7 million of non-cash stock-based
compensation expense, in the fourth quarter of 2023 compared to
$89.3 million, including $4.9 million of non-cash stock-based
compensation expense, for the same period in 2022. For the fourth
quarter of 2023, the decrease in R&D expenses as compared to
the same period in 2022 was primarily related to reorganization
cost savings measures including reduced headcount, budgeted
expenditures and reprioritization of early-stage pipeline programs.
For the year ended December 31, 2023, R&D expenses were $356.2
million, including $24.8 million of non-cash stock-based
compensation expense, compared to $326.2 million, including $25.9
million of non-cash stock-based compensation expense, for the same
period in 2022. For the year, the increase in R&D expenses was
primarily due to increased headcount, and spending on zuranolone
(ZURZUVAE) and Sage’s wholly owned pipeline, including dalzanemdor
(SAGE-718) and other programs. The reimbursement from Biogen to
Sage for R&D expenses pursuant to the Sage/Biogen Collaboration
and License Agreement was $76.2 million in 2023 compared to $73.2
million in the same period of 2022.
- SG&A Expenses: Selling, general and administrative
expenses were $55.1 million, including $8.3 million of non-cash
stock-based compensation expense, in the fourth quarter of 2023,
compared to $67.3 million, including $10.4 million of non-cash
stock-based compensation expense, for the same period in 2022. For
the fourth quarter of 2023, the decrease in SG&A expenses as
compared to the same period in 2022 was primarily related to
reorganization cost savings measures including reduced headcount
and budgeted expenditures. For the year ended December 31, 2023,
SG&A expenses were $274.5 million, including $47.7 million of
non-cash stock-based compensation expense, compared to $227.7
million, including $35.7 million of non-cash stock-based
compensation expense, for the same period in 2022. The increase in
SG&A expenses year-over year was primarily due to hiring
employees in the first half of 2023 to support ongoing permitted
pre-launch and launch-readiness activities with respect to
ZURZUVAE, in anticipation of commercialization of ZURZUVAE,
and stock-based compensation expense related to the vesting of
certain milestones. The reimbursement from Sage to Biogen for
SG&A expenses pursuant to the Sage/Biogen Collaboration and
License Agreement was $16.5 million in 2023 compared to $2.2
million of reimbursement from Biogen to Sage in the same period of
2022. The primary reason for the decrease in net reimbursement from
Biogen to Sage was an increase in the collaboration costs incurred
by Biogen in anticipation of the commercialization of
ZURZUVAE.
- Restructuring Expenses: Restructuring expenses were
$33.4 million for the year ended December 31, 2023 due to the
August 2023 corporate reorganization, with the majority of expense
incurred during the third quarter of 2023. No restructuring
expenses were incurred in the same period of 2022.
- Net Loss: Net loss was $32.7 million for the fourth
quarter of 2023 compared to $147.1 million for the same period in
2022. For the year ended December 31, 2023, net loss was $541.5
million compared to $532.8 million for the same period in
2022.
FINANCIAL GUIDANCE
- Based upon the Company's current operating plan, Sage
anticipates that its existing cash, cash equivalents and marketable
securities, along with the milestone payment received in January
2024, anticipated funding from ongoing collaborations, and
estimated revenues, will support its operations into 2026.
- The Company does not anticipate receipt of any milestone
payments from collaborations in the remainder of 2024.
- The Company anticipates operating expenses will decrease in
2024 relative to 2023.
- With the availability of ZURZUVAE as an additional treatment
for women with PPD, the Company anticipates ZULRESSO revenues will
decrease over time.
Conference Call Information Sage will host a conference
call and webcast today, Wednesday, February 14, at 8:00 a.m. ET to
review its fourth quarter and full year 2023 financial results and
discuss recent corporate updates. The live webcast can be accessed
on the investor page of Sage's website at investor.sagerx.com. A
replay of the webcast will be available on Sage's website following
the completion of the event and will be archived for up to 30
days.
About Sage Therapeutics
Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company
committed to our mission of pioneering solutions to deliver
life-changing brain health medicines, so every person can thrive.
Sage developed the only two FDA-approved treatments indicated for
postpartum depression and is advancing a robust pipeline to target
unmet needs in brain health. Sage was founded in 2010 and is
headquartered in Cambridge, Mass. Find out more at www.sagerx.com
or engage with us on Facebook, LinkedIn, Instagram, and X.
Forward-Looking Statements
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation our
statements regarding: our plans, expectations and goals for
commercialization of ZURZUVAE as a treatment for women with PPD,
including our goals for ZURZUVAE to become the first line treatment
and standard of care in this indication; our belief in the
potential for ZURZUVAE and our belief that ZURZUVAE will be
successful in helping women with PPD; anticipated timelines for
completion of enrollment in clinical trials and reporting of
results with respect to certain of our other programs; 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; our belief as to the key catalysts for our
business and potential value creation; and the mission and goals
for our business. 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 from sales of ZURZUVAE at the levels
or on the timing we expect or at levels or on the timing necessary
to support our goals; early positive signs from launch or from our
engagements with healthcare professionals, patients and payors
related to ZURZUVAE may not be a signal of the potential for future
success; the number of women with PPD, the unmet need for
additional treatment options, and the potential market for ZURZUVAE
in women with PPD, may be significantly smaller than we expect;
ZURZUVAE may not achieve the clinical benefit, clinical use or
level of market acceptance from healthcare professionals, patients
or payors in the treatment of PPD we expect or we may encounter
reimbursement-related or other market-related issues or issues with
our distribution network that impact the success of our
commercialization efforts, including our ability to achieve access
goals; ZURZUVAE may never become the first line treatment and
standard of care for women with PPD; we may encounter delays in
initiation, conduct, completion of enrollment or completion and
reporting of data with respect to any of our ongoing 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 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 or the timing of meetings with the FDA may affect the
timing, design, size, progress and cost of clinical trials or the
timing of data read-outs or our ability to proceed with further
development or may impair the potential for successful development
or the timing or success of filing for and gaining regulatory
approval; we may encounter adverse events at any stage that
negatively impact further development and the potential for
approval of our product candidates or the potential for successful
commercialization of any our products or that require additional
nonclinical and clinical work which may not yield positive results;
the need to align with our collaborators may hamper or delay our
development and commercialization efforts for the products or
product candidates that are part of the collaboration or increase
our costs; the anticipated benefits of our ongoing collaborations,
including the receipt of payments or the successful development or
commercialization of products and generation of revenue, may never
be achieved at the levels or timing we expect or at all; 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; 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 change or curtail some of our plans or both;
we may not be successful in our efforts to gain regulatory approval
of products beyond ZURZUVAE and ZULRESSO; we may not achieve
revenues from our products that may be successfully developed in
the future, at levels we expect; additional funding may not be
available on acceptable terms when we need it which could hamper
our development and commercialization activities; any of the
foregoing events could impair the value creation opportunities for
our business; 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 annual or quarterly report filed
with the Securities and Exchange Commission, 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)
December 31, 2023
December 31, 2022
Cash, cash equivalents and marketable securities
$
753,184
$
1,272,494
Total assets
882,277
1,356,449
Total liabilities
82,747
103,850
Total stockholders' equity
799,530
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 December
31,
Year Ended December
31,
2023
2022
2023
2022
Product revenue, net
$
1,985
$
2,865
$
10,454
$
7,686
License and milestone revenue - related party
75,000
-
75,000
-
Collaboraion revenue - related party
824
-
824
-
Other Collaboration revenue
163
-
177
-
Total revenue
77,972
2,865
86,455
7,686
Operating costs and expenses: Cost of goods sold
819
143
2,159
813
Research and development
64,330
89,295
356,235
326,163
Selling, general and administrative
55,109
67,329
274,524
227,699
Restructuring
(212)
-
33,386
-
Total operating costs and expenses
120,046
156,767
666,304
554,675
Loss from operations
(42,074)
(153,902)
(579,849)
(546,989)
Interest income, net
9,467
6,793
38,743
14,190
Other income (expense), net
(99)
(37)
(383)
15
Net loss
$
(32,706)
$
(147,146)
$
(541,489)
$
(532,784)
Net loss per share - basic and diluted
$
(0.55)
$
(2.47)
$
(9.05)
$
(8.98)
Weighted average shares outstanding - basic and diluted
59,990,004
59,494,613
59,836,441
59,306,094
SELECT IMPORTANT SAFETY INFORMATION FOR
ZURZUVAE
ZURZUVAE (zuranolone) CIV, is a neuroactive steroid
gamma-aminobutyric acid (GABA) A receptor positive modulator
indicated for the treatment of postpartum depression in adults.
This does not include all the information needed to use ZURZUVAE
safely and effectively. See full prescribing information for
ZURZUVAE.
ZURZUVAE may cause serious side effects, including decreased
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. You may not be able to tell on
your own if you can drive safely or tell how much ZURZUVAE is
affecting you. ZURZUVAE may cause central nervous system (CNS)
depressant effects including sleepiness, drowsiness, slow thinking,
dizziness, confusion, and trouble walking. Taking alcohol, other
medicines that cause CNS depressant effects such as
benzodiazepines, or opioids while taking ZURZUVAE can make these
symptoms worse and may also cause trouble breathing. ZURZUVAE is a
federally controlled substance schedule IV because it contains
zuranolone, which can be abused or lead to dependence. Tell your
healthcare provider right away if you become pregnant or plan to
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. 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. 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.
SELECT IMPORTANT SAFETY INFORMATION for
ZULRESSO
ZULRESSO (brexanolone) CIV, is a neuroactive steroid
gamma-aminobutyric acid (GABA) A receptor positive modulator
indicated for the treatment of postpartum depression in individuals
15 years and older.
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)
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/20240214365148/en/
Investor Ashley Kaplowitz 786-252-1419
ashley.kaplowitz@sagerx.com
Media Matthew Henson 917-930-7147
matthew.henson@sagerx.com
Sage Therapeutics (NASDAQ:SAGE)
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From Apr 2024 to May 2024
Sage Therapeutics (NASDAQ:SAGE)
Historical Stock Chart
From May 2023 to May 2024