The antidepressant drug gets support from FDA
The hallucinogenic party drug, ketamine has passed the final problem for going into the clinical stage as an antidepressant.
The US Food and Drug Administration (FDA), an independent advisory committee, supported in favour of commending a compound known as esketamine, used for treating depression. If the FDA gives a nod to the drug, it could encourage the chances of other ketamine-inspired treatments that are presently under development. Nonetheless, issues remain about esketamine’s overall effectiveness regarding lifting mood and its potential to be exploited.
Ketamine, which is a mixture of two molecules, is not understood by researchers how they are mirror images of each other. But the scientists know that it acts swiftly to ease symptoms of depression.
Ketamine that can be abused, is already approved for the use as an anaesthetic. It cannot be patented. So, a slew of companies is chasing patentable compounds that emulate ketamine’s structure and apparent effects like- the speed with which it works. Johnson & Johnson (J&J) of New Brunswick, New Jersey has made Esketamine that contains only one of the molecules that make up ketamine.
J&J showed the results from five phases III trials and other smaller trials of the drug that altogether included more than 1,700 people. Only two of the five phase III trials displayed positive results. Also, the people, who had esketamine, showed improvement that is slightly more than those, who had a placebo.
The two FDA panellists who had not favoured esketamine showed the slight improvement, worries over the drug’s side effects that include temporary dissociative and hallucinatory effects similar to ketamine, and the potentiality of the drug that it could be abused.
However, the people who had favoured to endorse the drug to the FDA showed considerations that includes patient preferences and the probability of being used by some people.
Moving forward with caution
Agency officials proposed that if the FDA gives a nod to esketamine, then it is probably that the patients receive the drug in a healthcare provider’s office. Also, they will be supervised for about two hours. They may require J&J to keep a registry of people who get it and track them for their long-term health for years.
Very little is recognised about how ketamine responds to depression and its long-term effects. But as of now, it could be an effective treatment for a few people with severe forms of depression.
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