FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder

Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) approved ZURZUVAETM (zuranolone) 50 mg for adults with postpartum depression (PPD). ZURZUVAE is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD. ZURZUVAE is expected to launch and be commercially available in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the U.S. Drug Enforcement Administration, which is anticipated to occur within 90 days.

Additionally, the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for zuranolone in the treatment of adults with major depressive disorder (MDD). The CRL 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 and evaluating next steps.

“Maternal mental health has been sidelined for far too long, but today’s approval of ZURZUVAE helps to change that. Women have been waiting for an oral medicine that can specifically and rapidly improve the symptoms of PPD and we are proud to be able to deliver that,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “In regard to the CRL for MDD, we are highly disappointed for patients, particularly amid the current mental health crisis and millions of people with MDD struggling to find symptom relief. We remain committed to our mission to deliver life-changing brain health medicines.”

“The approval of ZURZUVAE to treat postpartum depression is a major milestone for the hundreds of thousands of women who experience this underdiagnosed and undertreated condition,” said Christopher A. Viehbacher, President and Chief Executive Officer at Biogen. “We appreciate the support of patients, patient advocates and researchers who helped to reach this milestone. We believe that ZURZUVAE will be an important option to treat PPD and we will thoroughly review the feedback from the FDA on the use of zuranolone in MDD to determine next steps.”

The approval of ZURZUVAE to treat women with PPD is based on the NEST clinical development program, which included two studies in adult women with PPD (ROBIN and SKYLARK Studies). Both studies met their primary endpoint, a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, a common measure of depression severity, at Day 15 as compared to placebo. In the SKYLARK Study evaluating ZURZUVAE 50 mg, all key secondary endpoints were met, with significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45. ZURZUVAE was generally well-tolerated with a consistent safety profile across both studies. The most common side effects >5% and greater than placebo in patients treated with ZURZUVAE 50 mg were somnolence, dizziness, diarrhea, fatigue and urinary tract infection. The labeling includes a boxed warning that instructs healthcare providers to advise people that ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects. People who take ZURZUVAE should not drive a motor vehicle or engage in other potentially hazardous activities that require complete mental alertness until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. Patients may not be able to assess their own degree of impairment.

“Today marks a groundbreaking day for the treatment of PPD, as with ZURZUVAE we now have an oral treatment option that can provide rapid improvements in depressive symptoms in as early as three days for women with PPD,” said Dr. Kristina Deligiannidis, a principal investigator in the ZURZUVAE clinical development program and Professor, The Feinstein Institutes for Medical Research in Manhasset, New York. “As a perinatal psychiatrist, I see the devastating impact PPD has on mothers particularly on the important mother-infant bond and long-term child development. Once available, I believe ZURZUVAE will be a meaningful option for patients in need.”

According to the Centers for Disease Control and Prevention, mental health conditions are the leading cause of maternal mortality1 with PPD among the most common complications during and after pregnancy.2 In the U.S., it is estimated approximately 1 in 8 women experience symptoms of PPD.3 Approximately half of all PPD cases may go undiagnosed without appropriate screening.4,5 Research shows only 15.8% of women with PPD symptoms receive treatment.6 PPD symptoms may persist beyond the postpartum period and can lead to prolonged maternal morbidity.7-9 Symptoms of PPD can include depressed mood, loss of interest in activities, changes in sleep patterns and appetite, decreased energy, feelings of guilt or worthlessness, trouble concentrating and in some cases thoughts of suicide.9

“Today’s approval is welcome news for the estimated 500,000 women in the United States who report experiencing symptoms of this devastating and often misunderstood illness each year,” said Wendy N. Davis, Ph.D., PMH-C, Executive Director at Postpartum Support International. “Women with PPD desperately need prompt care and additional treatment options that can provide quick relief so they can be healthy and present during this momentous time in their lives.”

Important Safety Information

What is ZURZUVAE (zur-ZOO-vay)?

ZURZUVAE is a prescription medicine used to treat adults with postpartum depression (PPD). It is not known if ZURZUVAE is safe and effective in children.


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.

Source: https://www.businesswire.com/

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