Highlights:
There might be good news for those suffering from major depressive disorder (MDD) and postpartum depression (PDD) because the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone.
Zuranolone is used in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD.The application has been granted priority review (1✔ ✔Trusted Source- Postpartum depression affects 1 in 8 women and can seriously impact both the mother and the baby
- Zuranolone is an oral, investigational drug used for the treatment of postpartum depression
- FDA accepts New Drug Application and grants priority review of Zuranolone
Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
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Post-Partum Depression Calculator
Are you suffering from depression after the delivery of your baby. This can be harmful to both you and your baby. Use this seven questions screening test to rule it out.
Are you suffering from depression after the delivery of your baby. This can be harmful to both you and your baby. Use this seven questions screening test to rule it out.
‘Zuranolone, a drug used for postpartum depression, has been accepted for the filing of a New Drug Application (NDA) by the FDA.’
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What is Zuranolone?
Zuranolone (SAGE-217/BIIB125) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function.Advertisement
Test Your Knowledge on Postpartum Depression (PPD)
Introduction
Postpartum depression (PPD) is a condition faced by mothers following childbirth. It is characterized by severe mood swings, restlessness, difficulty deciding, difficulty bonding with the baby, crying, disturbed sleep and appetite, lack of motivation, fatigue, negative thought patterns, anxiety and thoughts of harming the baby or oneself.
Baby blues or postpartum dysphoria is a less intense version of the same that lasts for a shorter time and is seen in 50% to 75% of women. PPD is seen in about 17% of women. It is caused by both physical and emotional factors. Early interventions help to manage the condition.
Introduction
Postpartum depression (PPD) is a condition faced by mothers following childbirth. It is characterized by severe mood swings, restlessness, difficulty deciding, difficulty bonding with the baby, crying, disturbed sleep and appetite, lack of motivation, fatigue, negative thought patterns, anxiety and thoughts of harming the baby or oneself.
Baby blues or postpartum dysphoria is a less intense version of the same that lasts for a shorter time and is seen in 50% to 75% of women. PPD is seen in about 17% of women. It is caused by both physical and emotional factors. Early interventions help to manage the condition.
Use of Zuranolone for Depression and Postpartum Depression
In people with depression, Zuranolone is thought to work by rapidly rebalancing dysregulated neuronal networks to help reset brain function. Zuranolone targets brain networks responsible for functions such as mood, arousal, behavior, and cognition.“We see potential for zuranolone, if approved, to be a meaningful new option that can help address the serious unmet need faced by the diverse populations struggling with MDD and PPD. The FDA filing acceptance and granting of priority review are important milestones in the mission Biogen and our collaboration partner Sage share to advance the understanding and treatment of depression,” said Priya Singhal, M.D., M.P.H., Executive Vice President, Head of Development and Interim Head of Research and Global Safety and Regulatory Sciences at Biogen.
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Holistic Management of Post-Natal Depression
Post-natal depression can affect mother-infant bonding and other serious consequences. But it is a treatable condition and can be managed holistically.
Post-natal depression can affect mother-infant bonding and other serious consequences. But it is a treatable condition and can be managed holistically.
Impact of Depression on Population
Depression is one of the leading contributors to disability worldwide. Approximately, more than 21 million adults in the U.S. experienced at least one major depressive episode in 2020. Almost 14 million people are diagnosed with major depressive disorder, and an estimated 500,000 cases of PPD annually.Symptoms of MDD and PPD have been shown to have an impact on a person’s overall quality of life, functioning, and well-being. In 2018, the incremental economic burden of MDD was an estimated $326 billion in the U.S. alone.
Postpartum Depression- A Major Concern Among Indian Women
Postpartum depression is a major health care condition that manifests in women a few weeks after childbirth.
Postpartum depression is a major health care condition that manifests in women a few weeks after childbirth.
The Need for Better Treatment for Depression
“We feel a tremendous responsibility to patients with MDD and PPD to deliver a potential new treatment option, which is so desperately needed. Most currently approved therapies may take weeks or months to work. We are committed to advancing treatments that could help physicians and patients by addressing depression symptoms quickly,” said Laura Gault, M.D., Ph.D., Chief Medical Officer at Sage. “We believe zuranolone, if approved, could offer a new way for physicians to support patients.”About Major Depressive Disorder (MDD)
Major depressive disorder (MDD) is a common but serious mood disorder in which people experience depressive symptoms that impair their social, occupational, educational, or other important functioning, such as a depressed mood or loss of interest or pleasure in daily activities, consistently for at least a two-week period. It is estimated that in 2020, more than 21 million adults in the U.S. experienced at least one major depressive episode with nearly 14 million people diagnosed with major depressive disorder.2 There were approximately 190 million cases of MDD worldwide in 2020.5About Postpartum Depression (PPD)
Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy. PPD can have a serious negative impact on a woman, including 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. PPD is estimated to affect approximately one in eight women who have given birth in the U.S. or approximately 500,000 women annually.Priority Review is granted by the FDA to applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions.
References:
- Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression - (https://investors.biogen.com/news-releases/news-release-details/biogen-and-sage-therapeutics-announce-fda-accepts-filing-new)
Source-Medindia
