Johnson & Johnson announced in the first time in Europe the third phase of clinical data on esketamine treatment of drug-resistant depression
June 21, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];American medical giant Johnson & Johnson (JNJ) recently announced the key phase III clinical study of the new antidepressant esketamine nasal spray for the treatment of refractory depression at the 31st International Society for Neuropsychopharmacology (CINP) in Vienna, Austria. data. This is the first time the company has published data on the esketamine clinical project in Europe, mainly from four studies:
1. Maintenance period results for a long-term relapse prevention study: data show that patients treated with oral antidepressants combined with esketamine nasal spray for more than 16 weeks are delayed compared with an oral antidepressant and placebo nasal spray There was a clinically and statistically significant advantage in the timing of relapse of depressive symptoms (bilateral test p=0.003). In addition, data showed that patients receiving oral antidepressants combined with esketamine nasal sprays achieved a 51% reduction in the risk of recurrence in patients with stable remission compared with oral antidepressants and placebo nasal sprays (remaining patients with relapsed disease) Proportion: esketamine vs placebo: 26.7% vs 45.3%, estimated HR = 0.49, 95% CI: 0.29-0.84). The five most common adverse reactions reported during the maintenance period include temporary loss of taste, dizziness, dissociation, lethargy, and dizziness.
2. A long-term safety study: data show that in adults with refractory depression, oral antidepressants combined with esketamine nasal sprays are generally well tolerated for one year (52 weeks), no new Safety signal. In this study, the safety of esketamine was similar to that of the previously published short-term Phase II and III clinical studies in the treatment of refractory depression. Data from the open-label study also showed that oral antidepressants combined with esketamine nasal spray treatment appeared to be associated with continued improvement in depressive symptoms for up to 52 weeks. The most common treatment-related adverse events (incidence ≥10%) include dizziness, dissociation, nausea, headache, lethargy, temporary loss of taste, decreased oral touch or sensation, dizziness, vomiting, viral upper respiratory tract infection.
3. A short-term, randomized, double-blind, positive-controlled study in adult patients with refractory depression: data showing esketamine compared with placebo nasal spray and a newly initiated oral antidepressant treatment Nasal sprays and a newly initiated oral antidepressant treatment resulted in a statistically significant and clinically significant reduction in depressive symptoms (one-sided p=0.01). The study showed that esketamine and an antidepressant treatment have clinically significant advantages compared with a positive control drug, especially in adult patients who are considered to be refractory depression. In this study, the most common adverse events (incidence >10%) in the esketamine-treated group were temporary loss of taste, nausea, dizziness, dizziness, headache, lethargy, transient sensory changes, blurred vision, and paresthesia (tingling) And anxiety. The most common treatment-related adverse events (incidence >10%) in the placebo and oral antidepressant treatment groups were temporary loss of taste and headache.
4. A short-term, randomized, double-blind, positive-controlled study of elderly patients with refractory depression aged 65 years and older: this is a patient cohort that has historically been difficult to treat, data showing, and a new start-up Compared with placebo nasal spray, the flexible dose of esketamine nasal spray and a newly initiated oral antidepressant treatment showed clinically significant efficacy, but did not reach statistical significance (unilateral p =0.029). In the study, the most common treatment-related adverse events (>10%) in the esketamine-treated group included dizziness, nausea, headache, fatigue, elevated blood pressure, dizziness, dissociation, and sensory changes. There were no treatment-related adverse events with an incidence of >10% in the oral antidepressant and placebo nasal spray treatment groups.
Professor Siegfried Kasper, head of the Department of Psychiatry and Psychotherapy at the Vienna Medical University, said that severe depression affects approximately 300 million people worldwide. The disease significantly affects patients' quality of life and physical and social functions. Although there are currently listed drugs, there are about 1/ 3 patients did not respond to these drugs and were considered to be refractory depression. Therefore, it is very important to continue to study and report on the results of research in this field. The data presented here provide insights into the efficacy and safety of esketamine in the treatment of refractory depression in both short- and long-term treatments, and suggest that esketamine significantly delays the onset of depressive symptoms in this highly therapeutic patient population.
Dr. Mathai Mammen, Global Development Director of Johnson & Johnson, Johnson & Johnson, said that he is pleased to share with the medical community the Phase III project data for esketamine nasal sprays, which enhances the potential of esketamine to help those who are unresponsive to existing antidepressant treatments. . We look forward to submitting esketamine project data to regulatory agencies to bring a new treatment option to patients in need.
Esketamine is a non-competitive and subtype non-selective activity-dependent N-methyl-D-aspartate (NMDA) receptor antagonist. The drug has a completely new unique mechanism of action, its principle of action and current Other drugs for treating depression vary in the market.
The amazing thing about esketamine is that it has a fast-acting, long-lasting and powerful effect in patients with refractory depression. The data show that for most patients with depression who are refractory to antidepressants on the market, when they turn to esketamine, the patient's mood is significantly improved within a few days of treatment, and the effect lasts for a long time. Most antidepressants currently on the market often take weeks or even months to work.
In the United States, the FDA has granted esketamine the treatment of refractory depression and the treatment of severe drug breakout drugs with a risk of urgent suicide. If approved, the drug will be one of the first new drugs approved by the FDA for the treatment of major depression in the past 50 years. Intranasal esketamine administration will provide a quick onset of efficacy compared to standard oral treatments. (Sina Pharmaceutical Compilation/newborn)
Article Reference Source: Janssen Phase 3 Study Programme of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Presented for the First Time in Europe
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