Approval based on results from three pivotal
trials showing treatment with ZULRESSO provided significant and
rapid reduction of depressive symptoms within days
Postpartum depression is the most common
medical complication of childbirth, estimated to affect
approximately 400,000 women annually in the U.S.
Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company
developing novel medicines to treat life-altering central nervous
system (CNS) disorders, announced today the U.S. Food and Drug
Administration (FDA) has approved ZULRESSOTM (brexanolone)
injection for the treatment of postpartum depression (PPD).
ZULRESSO is the first and only medicine specifically approved to
treat PPD, the most common medical complication of childbirth.
ZULRESSO is expected to be available in late June following
scheduling by the U.S. Drug Enforcement Administration, which is
expected to occur within 90 days.
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“Today’s approval of ZULRESSO represents a game-changing
approach to treating PPD,” said Samantha Meltzer Brody, M.D.,
M.P.H., Ray M Hayworth Distinguished Professorship of Mood and
Anxiety Disorders and director of the Perinatal Psychiatry Program,
UNC Center for Women’s Mood Disorders and primary investigator of
the ZULRESSO clinical trials. “The potential to rapidly reduce
symptoms in this critical disorder is an exciting milestone in
women’s mental health. PPD is recognized to have a significant and
long-term impact on women and their families, but with ZULRESSO we
may finally have the opportunity to change that.”
PPD can affect women during pregnancy or after childbirth. It is
estimated PPD affects approximately one in nine women who have
given birth in the U.S. Symptoms may include sadness, anxiety,
irritability, withdrawing from friends or family, having trouble
bonding with her baby and thinking about harming herself or more
rarely, her baby. Without proper screening, up to half of PPD cases
may go undiagnosed.
ZULRESSO was evaluated by the FDA under Priority Review, which
is reserved for investigational therapies that, if approved, may
offer significant improvements in the treatment, prevention or
diagnosis of a serious condition. In 2016, ZULRESSO was also
granted Breakthrough Therapy Designation status, underscoring the
significant unmet need in women with PPD.
“We are proud to be a part of this important moment in mental
health, creating the opportunity for an unprecedented change in the
way postpartum depression is thought about and treated moving
forward,” said Jeff Jonas, M.D., chief executive officer of Sage.
“We are grateful for the patients, researchers, healthcare
providers, advocates, caregivers and Sage employees who helped
secure the approval of the first medicine specifically for
postpartum depression. Not only do we believe ZULRESSO will address
an important need for women’s mental health, the impact of PPD is
multi-generational, and we look forward to bringing ZULRESSO to
patients in urgent need of a new treatment option. We believe
ZULRESSO will be a catalyst in starting a new dialogue emphasizing
the importance of women’s mental health, and the importance of
diagnosing and treating PPD.”
The FDA approval of ZULRESSO is based on findings from three
multicenter, randomized, double-blind, parallel-group,
placebo-controlled trials, designed to evaluate the safety and
effectiveness of ZULRESSO in women with moderate and severe PPD,
aged between 18 and 45 years who were ≤6 months postpartum at
screening and who had onset of symptoms no earlier than the third
trimester and no later than the first four weeks following
delivery.
In all trials at all doses, ZULRESSO achieved the primary
endpoint, a significant mean reduction from baseline in the
Hamilton Rating Scale for Depression (HAM-D) total score, a common
measure of depression severity, at 60 hours compared to placebo. A
reduction of depressive symptoms was also seen as early as 24
hours, and ZULRESSO maintained effect through the 30-day follow-up.
The most common adverse events in the studies were sleepiness, dry
mouth, loss of consciousness and flushing.
About Postpartum DepressionPostpartum depression (PPD) is
the most common medical complication of childbirth. PPD is a
distinct and readily identified major depressive disorder that can
occur during pregnancy or after giving birth. Expert opinions vary
as to the timing of the onset of PPD, ranging from onset during
pregnancy up to 4-weeks postpartum and onset during pregnancy up to
12-months postpartum. PPD may have devastating consequences for a
woman and for her family, which may include significant functional
impairment, depressed mood and/or loss of interest in her newborn,
and associated symptoms of depression such as loss of appetite,
difficulty sleeping, motor challenges, lack of concentration, loss
of energy and poor self-esteem. Suicide is the leading cause of
maternal death following childbirth. PPD affects approximately one
in nine women who have given birth in the U.S. and 400,000 women
annually. More than half of these cases may go undiagnosed without
proper screening.
About ZULRESSO® (brexanolone)
injectionZULRESSO, the first medicine specifically approved by
the U.S. Food and Drug Administration for the treatment of
postpartum depression, is an allosteric modulator of both synaptic
and extrasynaptic GABAA receptors. Allosteric modulation of
neurotransmitter receptor activity results in varying degrees of
desired activity rather than complete activation or inhibition of
the receptor. ZULRESSO is approved by the FDA for the treatment of
PPD in adults, pending DEA scheduling. ZULRESSO has been granted
PRIority MEdicines (PRIME) designation from the European Medicines
Agency (EMA).
Important Safety Information:
What is ZULRESSO™?
ZULRESSO is a prescription medicine used in adults to treat a
certain type of depression called Postpartum Depression.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
ZULRESSO?
ZULRESSO can cause serious side effects, including:
- Excessive sedation and sudden loss
of consciousness. ZULRESSO may cause you to feel very sleepy
(excessive sedation) or pass out (loss of consciousness). Your
healthcare provider should check you for symptoms of excessive
sleepiness every 2 hours while you are awake.
- During your ZULRESSO infusion, tell
your healthcare provider right away if you feel like you cannot
stay awake during the time you are normally awake or if you feel
like you are going to pass out. Your healthcare provider may lower
your dose or stop the infusion until symptoms go away.
- You must have a caregiver or family
member with you to help care for your child(ren) during your
ZULRESSO infusion.
- Because of the risk of serious harm
resulting from excessive sedation or sudden loss of consciousness,
ZULRESSO is only available through a restricted program called the
ZULRESSO REMS.
Before receiving ZULRESSO, tell your healthcare provider
about all your medical conditions, including if you:
- drink alcohol
- have kidney problems
- are pregnant or think you may be
pregnant. It is not known if ZULRESSO will harm your unborn baby.
- There is a pregnancy registry for
females who are exposed to ZULRESSO during pregnancy. The purpose
of the registry is to collect information about the health of
females exposed to ZULRESSO and their baby. If you become pregnant
during treatment with ZULRESSO, talk to your healthcare provider
about registering with the National Pregnancy Registry for
Antidepressants at 1-844-405-6185 or visit
https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to
breastfeed. ZULRESSO passes into breast milk. Talk to your
healthcare provider about the risks and benefits of breastfeeding
and about the best way to feed your baby while receiving
ZULRESSO.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
ZULRESSO and some medicines may interact with each other and
cause serious side effects.
Especially tell your healthcare provider if you take
other antidepressants, opioids, or Central Nervous System (CNS)
depressants (such as benzodiazepines).
Know the medicines you take. Keep a list of them to show your
healthcare provider and pharmacist when you get a new medicine.
Your healthcare provider will decide if other medicines can be
taken with ZULRESSO.
How will I receive ZULRESSO?
ZULRESSO is given to you by continuous intravenous (IV) infusion
into your vein. The infusion will last for a total of 60 hours (2.5
days).
What should I avoid while receiving ZULRESSO?
- ZULRESSO may make you feel dizzy and
sleepy. Do not drive a car or do other dangerous activities after
your ZULRESSO infusion until your feeling of sleepiness has
completely gone away. See “What is the most important
information I should know about ZULRESSO?”
- Do not drink alcohol while receiving
ZULRESSO.
What are the possible side effects of ZULRESSO?
ZULRESSO can cause serious side effects, including:
- See “What is the most important
information I should know about ZULRESSO?”
- Increased risk of suicidal thoughts
or actions. ZULRESSO and other antidepressant medicines may
increase suicidal thoughts and actions in some people 24 years of
age and younger. Depression or other serious mental illnesses are
the most important causes of suicidal thoughts or actions.
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.
- 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, other unusual
changes in behavior or mood.
The most common side effects of ZULRESSO include:
- Sleepiness, dry mouth, passing out,
flushing of the skin or face.
These are not all the side effects of ZULRESSO.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 WARNING, and Medication Guide for ZULRESSO™ and
discuss any questions you may have with your healthcare
provider.
About Sage TherapeuticsSage Therapeutics is a
clinical-stage biopharmaceutical company committed to developing
novel medicines to transform the lives of patients with
life-altering CNS disorders. ZULRESSO™ (brexanolone) injection is a
rapidly acting GABA modulator now approved by the U.S. Food and
Drug Administration as the first and only treatment specifically
indicated for postpartum depression, pending DEA scheduling. Sage
is developing a portfolio of novel product candidates targeting
critical CNS receptor systems, including SAGE-217, which is in
Phase 3 development in major depressive disorder and postpartum
depression. For more information, please visit www.sagerx.com.
Forward-Looking StatementsVarious statements in this
release concerning Sage's future expectations, plans and prospects,
including without limitation: our expectations regarding scheduling
and future availability of ZULRESSO in the treatment of PPD; our
statements regarding the potential for ZULRESSO to rapidly resolve
PPD symptoms; our view of the potential of ZULRESSO to change the
way PPD is treated; our estimates as to the number of women with
PPD in the U.S. and rates of diagnosis; and our statements
regarding our portfolio of product candidates and our business
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: Drug
Enforcement Administration scheduling and launch of ZULRESSO may
not occur on the timelines we expect; we may encounter issues,
delays or other challenges in launching or commercializing
ZULRESSO, including issues related to market acceptance and
reimbursement, challenges related to limiting the site of
administration of the product to a certified healthcare facility
monitored by a qualified healthcare provider, and the necessity for
a Risk Evaluation and Mitigation Strategies plan; and challenges
associated with execution of our sales and patient support
activities, which in each case could limit the potential of our
product; results achieved with ZULRESSO in the treatment of PPD
once we have launched the product may be different than observed in
clinical trials, and may vary among patients; we may encounter
unexpected safety or tolerability issues with ZULRESSO or any of
our product candidates; the number of patients with PPD or the
unmet need for additional treatment options may be significantly
smaller than we expect; we may not be successful in our development
of any of our other product candidates in any indication we are
currently pursuing or may in the future pursue; success in early
stage clinical trials may not be repeated or observed in ongoing or
future clinical trials; and we may encounter technical and other
unexpected hurdles in the commercialization of ZULRESSO or in the
development, manufacture and potential future commercialization of
our product candidates; as well as those risks more fully discussed
in the section entitled "Risk Factors" in our most recent Annual
Report on Form 10-K filed with the Securities and Exchange
Commission (SEC), and discussions of potential risks,
uncertainties, and other important factors in our subsequent
filings with the SEC. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190319005938/en/
Investor Contact:Paul Cox,
617-299-8377paul.cox@sagerx.com
Media Contact:Jeff Boyle,
347-247-5089jeff.boyle@sagrerx.com
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