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    Home > Active Ingredient News > Study of Nervous System > New medicine for major depression (MDD)!

    New medicine for major depression (MDD)!

    • Last Update: 2021-06-21
    • Source: Internet
    • Author: User
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    News on June 15, 2021 // --Sage Therapeutics and Biogen recently announced that the double-blind placebo-controlled Phase 3 WATERFALL study evaluating the antidepressant zuranolone (SAGE-217/BIIB125) in patients with major depression (MDD) reached the primary endpoint: 17 according to the Hamilton depression Rating scale (HAMD-17) total score at day 15, compared with placebo, patients zuranolone 50mg treatment, depression -like statistically significant and clinically meaningful alleviate
    .
    The specific data are: on the 15th day, the change in the LS mean (SE) of the total score of HAMD-17 in patients treated with zuranolone 50 mg from baseline was -14.
    1 (0.
    51), while that of patients treated with placebo was -12.
    3 (0.
    50) (The difference in LS average is -1.
    7 points; p=0.
    0141)
    .
    Depression on day 15, compared with placebo, patients zuranolone 50mg treatment, depression -like statistically significant and clinically meaningful alleviate depression


    In addition, the results of HAMD-17 on the 3rd , 8th, and 12th days showed that the zuranolone treatment took effect quickly
    .
    Patients who responded to zuranolone on day 15 retained an average of 86% of the HAMD-17 improvement on day 42 (4 weeks after the end of dosing), indicating that zuranolone had a long-lasting effect
    .
    In this study, zuranolone was generally well tolerated and its safety was consistent with previous clinical studies
    .
    The results of HAMD-17 on days 3, 8, and 12 showed that patients who responded to zuranolone with a rapid onset of zuranolone treatment on day 15 retained an average of 86% of HAMD- on day 42 (4 weeks after the end of dosing).
    17 improved, indicating that zuranolone has a long-lasting effect
    .


    Anita H.
    Clayton, director of the Department of Psychiatry and Neurobehavioral Sciences at the University of Virginia School of Medicine, commented: "I am very excited about these breakthrough data: We know that the onset of MDD is sporadic, and zuranolone has the potential for sporadic treatment
    .
    The WATERFALL study and the previous LANDSCAPE study provide data on short-term and long-term use of zuranolone
    .
    These data show that if approved, zuranolone has the potential to act quickly in a short course of treatment, and is well tolerated, and can maintain long-term efficacy
    .
    "


    The chemical structure of zuranolone (picture source: biochempartner.
    com)

    For the past 60 years, monoamine antidepressants have been the standard treatment for long-term treatment of MDD
    .
    This type of drug is a daily treatment method that requires sufficient exposure and continuous use to maintain the efficacy
    .



    Zuranolone is a two-week, once-a-day oral medication that is currently being developed to treat MDD and postpartum depression (PPD)
    .
    The drug is a small molecule drug designed to provide a fast-acting and sustainable treatment plan, and may represent a breakthrough in current depression management
    .

    Depression


    Zuranolone is an oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM)
    .
    The GABA system is the main inhibitory signal pathway of the brain and central nervous system, and plays an important role in regulating brain function
    .
    Previously, the US FDA has granted zuranolone a breakthrough drug designation
    .
    FDA


    Clinical data of zuranolone (click on the picture to see a larger picture)

    WATERFALL is a pivotal, double-blind, randomized, placebo-controlled phase 3 study conducted in 18-64-year-old adults with MDD (N=543) to evaluate the efficacy and safety of zuranolone 50mg
    .
    The MDD patients enrolled in this study had a total score of HAMD-17 ≥ 24 points at the time of screening and 1 day before administration
    .
    In the study, patients were randomly assigned to receive zuranolone 50mg or placebo, and they were taken once every night for a total of 14 days of treatment
    .
    The primary endpoint of the study was the change from baseline in HAMD-17 total score on day 15; the first secondary endpoint was the change from baseline in clinical overall impression disease severity (CGI-S) on day 15
    .


    At the time of study entry, the mean (SD) baseline HAMD-17 scores of the zuranolone 50 mg treatment group (n=268) and placebo group (n=269) were 26.
    8 (2.
    60) and 26.
    9 (2.
    67), respectively
    .
    90.
    3% of the zuranolone 50mg treatment group and 87.
    4% of the placebo group completed the study
    .


    The above table lists the top-line results of the primary endpoint and several secondary efficacy endpoints during the treatment period.
    All results are in favor of zuranolone:
    The above table lists the top-line results of the primary endpoint and several secondary efficacy endpoints during the treatment period.
    All results are in favor of zuranolone:


    Patients in the zuranolone treatment group who responded to treatment on the 15th day retained an average of 86.
    1% of the HAMD-17 improvement on the 42nd day (4 weeks after the end of dosing)
    .
    A similar response was observed on the MADRS scale.
    Patients who responded to zuranolone on day 15 retained 87.
    6% of the response on day 42
    .
    Although not statistically significant, it showed a numerical advantage in favor of zuranolone on day 42
    .


    In this study, the adverse events are consistent with the safety of zuranolone observed in clinical studies so far
    .
    The incidence of adverse events (TEAE) during treatment in the zuranolone group was 60.
    1% (161/268), compared with 44.
    6% (120/269) in the placebo group
    .
    The majority of TEAEs were mild to moderate.
    In the zuranolone group and placebo group, 8 cases (3.
    0%) and 3 cases (1.
    1%) had serious TEAEs, respectively
    .
    ()


    Original Source: Sage Therapeutics and Biogen Announce Positive Pivotal Phase 3 Results for Zuranolone, an Investigational Two-Week, Once-Daily Therapeutic Being Evaluated for Major Depressive Disorder
    Sage Therapeutics and Biogen Announce Positive Pivotal Phase 3 Results for Zuranolone, an Investigational Two-Week, Once-Daily Therapeutic Being Evaluated for Major Depressive Disorder
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