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A Depression Drug Closer to FDA Approval


A Depression Drug Closer to FDA Approval

What if there was a medication for severe cases of depression that can work when others cannot? Recently, the Food and Drug Association took a new drug into consideration that is considered “the most important discovery in half a century” in regards to depression. If this drug gets approval, it is on the brink to becoming the first new federally-approved depression drug in over 35 years.

Esketamine is a nasal spray that was inspired by ketamine made by Johnson & Johnson for severe cases of depression when other medications do not work. We have medications like ketamine which has been used to help pain and prevent suicidal thoughts, but the drug is not cheap as each session costs $500-$750 and administered through an IV which take 45 minutes to two hours. Esketamine, on the other hand, will be taken as a nasal spray with a traditional antidepressant which will take less time to administer and less costly. The clinical trial suggested that the drug is safe to use. The only side effect to worry about with it is dissociation which was reported in over a third of patients in the last phase clinical trials. A third of patients also experienced dizziness, sedation, and nausea. Because of this, researchers believe that the drug should be taken with a clinician present who can monitor them for two hours after treatment.

Researchers on the FDA panel felt that the drug was more convenient than current antidepressants since the nasal spray does not require an IV and could be given once a week. In a study published in May of last year, 240 severely depressed adults took a traditional antidepressant with the nasal spray for a month. Half got a spray with esketamine and the other half got a placebo. The results showed that the people who got the real spray in the study saw much better improvements in their depressive symptoms than when they got a placebo.

On February, a panel of experts by the Food and Drug Administration voted 14 to 2 in favor of the drug’s effectiveness and 15 to 2 in the drug’s safety. They also voted 14 to 2 that the drug’s benefits outweigh the risks. Once the FDA decides to give esketamine approval, this will be the first federally-approved depression medication in four decades that can make a huge impact in the lives of those with severe depression.

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