New antidepressant drugs have been approved by the US FDA for breakthrough therapy
August 22, 2016 Source: WuXi PharmaTech
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)];Today, biopharmaceutical company Janssen Research & Development announced that the US FDA has granted its breakthrough anti-depression drug esketamine breakthrough therapy for major depressive disorder (Majordepressiondisorder). If approved by the FDA, esketamine will be the first new drug to treat major depression in the past 50 years.
Depression is a common mental disorder worldwide, with an estimated 350 million patients at all ages. Depression is different from a transient emotional response or fluctuation in daily life. Depression can be classified as mild, moderate, or severe depending on the number and severity of symptoms. Long-term patients with moderate or severe depression are greatly affected and cannot continue to engage in normal social activities, work and family life, with the most serious consequences leading to suicide.
The dangers caused by major depression are huge (Source: depression-symptoms.org)
Every year, more than 800,000 people worldwide die from suicide, many of which are caused by untreated or poorly treated major depression. Most of the existing depression treatment drugs have a certain effect on the monoamine neurotransmitter system, but they are often slower and take 3 to 6 weeks, so they are targeted at patients with severe depression who have an acute suicidal tendency. Limited value. Scientific researchers are constantly exploring the development of new antidepressants and expect to meet the potential needs of patients as quickly as possible.
Molecular properties of Esketamine (Source: forbes.com)
Esketamine intranasal is a new compound being studied by Janssen, a non-competitive, subtype non-selective, activity-dependent antagonist of the N-methyl-D-aspartate (NMDA) receptor. It has a new mechanism of action of drugs, unlike current depression therapies. This is also the second time that esketamine has obtained a breakthrough therapy approval from a US regulatory agency. In November 2013, esketamine was first awarded a breakthrough therapy for the treatment of resistant-pression.
Esketamine works quickly (Source: forbes.com)
In May 2016, at the 71st Annual Society of Biological Psychiatry Annual Meeting in Atlanta, Georgia, Janssen published Phase 2 clinical trial data for esketamine. These preliminary clinical evidence supports its breakthrough therapy for suicide-prone major depression.
Mechanism of action of Esketamine (Source: Depression & Anxiety)
Dr. Husseini K. Manji, global head of the Janssen Neuroscience Treatment Division, said: “In the United States alone, more than 40,000 people commit suicide each year, many of which are unfortunately due to untreated or mishandled major depression. Therapy recognizes the strengthening of esketamine as a new treatment option for the benefit of those with suicide risk. Currently, there are no approved treatments for this patient and it is a major public health challenge. We are conducting clinical trials. To further evaluate the clinical benefits of esketamine, and look forward to working closely with the FDA throughout the development and review process to facilitate the early approval of this important potential novel therapy for the benefit of patients."
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