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Sage Therapeutics Announces FDA Approval of ZULRESSO™ (brexanolone) Injection, the First and Only Treatment Specifically Indicated for Postpartum Depression


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.

This press release features multimedia. View the full release here:

"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

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

About Postpartum Depression
Postpartum 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) injection
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:


ZULRESSO is a prescription medicine used in adults to treat a certain
type of depression called Postpartum Depression.


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
  • 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

Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal

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
  • 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 Therapeutics
Sage 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

Forward-Looking Statements
Various 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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