A new treatment for depression, esketamine, is now on the fast row waiting to be approved by the FDA. The drug is a derivate of the popular street drug ketamine.
Ketamine is a powerful anesthetic and had been used to treat pain, depression, anxiety and post-traumatic stress disorder. However, the doctors preferred not to use it because of its hallucinogenic side effects.
If the drug obtains FDA’s approval, it will be the first major depression treatment entering the market in the last half of a century.
The FDA granted the designation of Breakthrough Therapy to esketamine, a drug developed by the Janssen Research & Development. The drug will be used as an antidepressant in patients going through a major depression episode with suicidal risks.
The esketamine had received the same designation in November 2013, pushing forward its development and receiving new timelines for approval. The preliminary trials show that the new medicine may have superior effects on one or more clinical factors involved in life-threatening conditions.
The phase 2 clinical trial data was presented at the Society of Biological Psychiatry Annual Scientific Meeting from Atlanta, Georgia. The researchers showed data that supports the positive outcome of an esketamine treatment for people who experience a major depression episode and have suicidal thoughts.
While there are more than 41,000 suicides every year in the US, the scientists say that the main reason for them is the lack of correct treatment for major depression. Suicide is considered to be a major public health challenge.
Almost 16 million people in the US are affected by major depression disorder. Worldwide, the number reaches 121 million. Depression is considered a biologically based disease that prevents individuals to enjoy life and to function properly, and it’s the psychiatric disorder most associated with suicide.
However, only 30% of the patients that are undergoing standard depression treatment are under remission. Conventional antidepressants can treat major depressive disorder and suicide ideation, but they are not approved for this use because they have a delayed effect of up to six weeks that limits their value.
Until now, there had been no approved treatment for people with a major depressive disorder that is at risk for suicide.
Eskamine is a subtype of the NMDA receptor antagonist that works differently than the other available treatments for depression.
At the moment, the treatment reached phase 3 of the development, involving six clinical trials.
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