Irish drug company Alkermes' antidepressant ALKS 5461 succeeded in a key phase III clinical trial
October 28, 2016 Source: Drug Information Network
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)];ALKS 5461 is a new, once-a-day trial that can be used as an adjunct to major depressive disorder (MDD). The positive clinical top-line data, called FORWARD-5, showed that ALKS 5461 significantly improved the patient's depressive symptoms compared with placebo, with statistically significant differences. In addition, patients are generally well tolerated by the drug, and common adverse events include dizziness, nausea, and fatigue. Based on the safety and efficacy data of FORWARD-5, Alkermes said that it plans to submit a listing application to the FDA's psychotropics department.
Alkermes' chief medical officer, Elliot Ehrich, said ALKS 5461 is a new antidepressant mechanism that can help patients who do not respond to conventional antidepressant treatment. The FORWARD-5 clinical trial included 407 patients with major depression. This positive clinical trial data led the company to believe the drug's effectiveness as an adjuvant treatment for major depression.
ALKS5461 is a combination of buprenorphine and Samidorphan (ALKS 33). The drug was approved by the FDA for rapid approval in 2013 for the treatment of major depression with no response to conventional therapy. However, two clinical trials of FORWARD-3 and FORWARD-4 showed that neither dose of ALKS5461 could effectively improve the patient's depressive symptoms, so it was delayed in the approval work, and the stock price was seriously affected. The positive data of the FORWARD-5 clinical trial can be regarded as a turnaround. With the accelerated pace of life and increased mental stress, depression has gradually entered the public eye, and can even be said to be a common disease. However, due to the more serious placebo effect in the development process, many companies have gradually abandoned this market. Therefore, the development of ALKS 5461 is good news for depression, especially for patients with major depression.
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