.jpeg)
zuranolone+标准抗抑郁药物可迅速缓解重度抑郁症患者的症状!
Introduction: Recently, Sage Therapeutics and Biogen jointly announced that the double-blind placebo-controlled Phase 3 CORAL study evaluating the antidepressant zuranolone combined with an open-label standard-of-care antidepressant (ADT) in the treatment of patients with major depressive disorder (MDD) met the primary and key secondary endpoints, with a statistically significant reduction in depressive symptoms on day 3 and 2 weeks of treatment.
About depression
Depression, also known as depressive disorder, is a common emotion-related mental illness in clinical practice. Its representative clinical manifestations are low mood, pessimism and world-weariness, and cognitive and sleep disorders. Patients often fall into melancholy, uncontrollable self-contemplation, and negative thinking about the past, present, and future. The etiology and pathogenesis of depression are relatively complex, involving biology, physiology and social living environment, etc. It can occur alone or at the same time as other diseases. In recent years, studies have found that patients with depression often have poor physiological functions, a higher risk of relapse, and even a very high suicide rate.
In recent years, research on the pathogenesis of depression and specific drug treatment targets has made rapid progress. Based on different pathogenesis, antidepressant drugs can be roughly divided into the following categories: monoamine oxidase inhibitors (MAOIs), tricyclic and tetracyclic antidepressants (TCAs), selective 5-HT reuptake inhibitors (SSRIs), 5-HT and NE reuptake inhibitors (SNaRIs), antidepressant traditional Chinese medicine, etc.
Aboutzuranolone
Zuranolone is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the main inhibitory signaling pathway in the brain and central nervous system and is involved in regulating brain function. Previously, the U.S. FDA had granted zuranolone breakthrough drug status.
Zuranolone is a 2-week, once-daily oral medication being developed to treat MDD and postpartum depression (PPD). The drug is a small molecule designed to provide a fast-acting, sustainable treatment option and may represent a breakthrough in current depression management.
Clinical research data
CORAL was an active-controlled trial evaluating zuranolone 50 mg plus open-label standard-of-care ADT versus standard-of-care ADT plus placebo. A total of 440 patients were enrolled in the study and were randomly divided into 2 groups: receiving zuranolone 50 mg combined with standard care ADT, or standard care ADT combined with placebo, once nightly for a total of 2 weeks. The researchers then followed the patients for four weeks, during which time they continued ADT.
The primary endpoint was the change from baseline in the HAMD-17 total score on Day 3. The data showed that on day 3, patients in the zuranolone+ADT treatment group (n=210) experienced a rapid and statistically significant reduction in depressive symptoms compared with the placebo+ADT treatment group (n=215), as measured by the LS mean (SE) change from baseline in the HAMD-17 total score (-8.9±0.39 vs -7.0±0.38; p=0.0004).
In the CORAL study, zuranolone 50 mg co-initiated with standard of care ADT was generally well tolerated and no new safety signals were identified. The majority of patients in the study experienced mild or moderate treatment-emergent adverse events (TEAEs), consistent with previous data from the LANDSCAPE program.
Depression is a mental disease with complex and diverse pathogenesis. Its typical characteristics are high morbidity, mortality and disability rates, which seriously threatens human physical and mental health. Although many drugs have been developed and approved for marketing, there has been a lack of more effective therapeutic drugs in clinical practice. Zuranolone has the potential to provide a new clinically meaningful treatment option for patients with major depressive disorder.
References
https://investors.biogen.com/news-releases/news-release-details/sage-therapeutics-and-biogen-announce-phase-3-coral-study-met
[ 免责声明 ] 本页面内容来自公开渠道（如FDA官网、Drugs官网、原研药厂官网等），仅供持有医疗专业资质的人员用于医学药学研究参考，不构成任何治疗建议或药品推荐。所涉药品可能未在中国大陆获批上市，不适用于中国境内销售和使用。如需治疗，请咨询正规医疗机构。本站不提供药品销售或代购服务。
