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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.
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)
.
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)..
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
.
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
.
"
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)
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
.
.
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.
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
.
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.
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
.
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
.
.
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
.
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:
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
.
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
.
()
.
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 
