The latest 3 data: eskamine nasal spray can quickly improve refractory depression
The latest 3 data: eskamine nasal spray can quickly improve refractory depression May 07, 2018 Source: Sina Pharmaceutical On May 5, Johnson & Johnson, a Johnson & Johnson company, announced the results of two clinical trials of esketamine nasal spray for the treatment of drug-resistant depression. These studies and results will be announced at the annual meeting of the American Psychiatric Association in New York on May 5-9. A study of adults with drug-resistant depression showed that a flexible dose of esketamine nasal spray combined with a newly started oral antidepressant treatment showed a combination of placebo nasal spray plus a new oral antidepressant treatment. Statistically significant and clinically significant depressive symptoms are rapidly reduced. This study defines treatment resistance as having no response to current two or more antidepressants in the current episode of depression, and the dose and duration of these drugs are sufficient. The second study was conducted in elderly patients with depression aged 65 years and older, the first of these studies. Studies have shown that flexible doses of esketamine plus a new oral antidepressant are clinically significant compared to placebo nasal spray plus a new oral antidepressant. However, this study barely reached the statistical significance of its primary efficacy endpoint. If approved by the US FDA, eskamine will be one of the first new methods to treat refractory depression in the past 50 years. Dr. Husseini K. Manji, global director of neuroscientific treatment at Janssen Pharmaceuticals, said: "Due to about 30% of people with major depression who fail to respond to existing antidepressants, drug-resistant depression has great medical needs. The positive results of clinical phase 3 of antidepressants are exciting, especially for the first time demonstrating the advantages of antidepressants compared to active comparators. More importantly, this relief is rapid, and this milestone It is achieved in patients who are considered to be resistant. We are also pleased to see that the use of esketamine nasal sprays in elderly patients is clinically significant, with a higher degree of disease and a lower rate of remission. †Mathai Mammen, director of global research and development at Janssen Pharmaceuticals, said: “For those with major depression who do not respond to existing therapies, new, rapid and effective treatment options are urgently needed. Janssen is fully committed to exploring the latest science in the field of emotional disorders, and Bring these findings to patients in need." The main efficacy results of adult antidepressant treatment: In this Phase III clinical study, patients were randomized to receive flexible doses of esketamine nasal spray (56 mg or 84 mg) plus new oral antidepressant therapy, or placebo nasal spray plus new Start oral antidepressant treatment. The primary efficacy endpoint of the study, the change in the total score of the Montgomery and Asperger Depression Rating Scale (MADRS) from baseline, showed depressive symptoms in the esketamine nasal spray plus oral antidepressant treatment group on day 28 Significant statistically significant improvement (standard deviation of least squares mean difference between placebo nasal spray plus a new oral antidepressant - 4.0 [1.69], 95% [CI]: -7.31, -0.64; one -sided p=0.010). Main efficacy outcomes in elderly patients with depression: Yang Sen conducted a separate phase 3 study of elderly patients with drug-resistant depression. Older people with severe depressive disorder have traditionally been difficult to treat and often suffer from concomitant diseases and long-term depression. To improve tolerance, patients were given a lower initial dose (28 mg) of esketamine nasal spray (28 mg, 56 mg or 84 mg flexible dose) plus freshly initiated oral antidepressant treatment. Although the statistical significance of the primary endpoint was marginally achieved throughout the study population, the results showed that treatment with eskamine nasal spray plus a new oral antidepressant group was better (compared to placebo nasal spray plus oral antibiotic) Median unbiased estimates of depression differences: -3.6, 95% CI: -7.20, 0.07; one-sided p=0.029). To use this as a background, placebo-controlled data from three previous studies conducted by Duru and Fantino were analyzed to determine that a minimal MADRS change of 1.9 was clinically significant. In addition, the average difference between currently approved antidepressants and placebo is 2-3 points. (Sina Pharmaceutical Compilation / David) Article, image reference source: New Phase 3 Data Show Esketamine Nasal Spray Demonstrated Rapid Improvements in Depressive Symptoms in Patients with Treatment-Resistant Depression Disposable Polyethylene Exam Gloves Medical Gloves,Disposable Pe Gloves,Disposable Polyethylene Gloves,Disposable Polyethylene Exam Gloves Henan Anbang Medical Supplies Co., Ltd. , https://www.anbangmedical.com