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A Ketamine based nasal spray for depression can soon be approved by the FDA



Photo: Teresa Crawford (AP)

One of the biggest obstacles to ketamine becoming a common depression treatment can just be cleared.

On Tuesday, an independent expert panel from the Food and Drug Administration discussed a nasal spray version of the drug developed by Johnson & Johnson should be approved by the FDA. In a majority vote, they agreed that the benefits of the drug outweigh the risks of treating depression thoughts that have not responded to other treatments but not without any conditions. The voice all but signals the drug's possible approval, since the FDA rarely strays off these decisions.

Ketamine has had a complicated history. Originally and still used as reassuring to humans and animals, it is also a common party substance, as it can lead to euphoric if disoriented high. For many years, however, doctors have experimented with using small doses of ketamine as a treatment for depression.

What is made ketamine as tempting as an antidepressant is that the effects in boosting mood appear to occur within hours or minutes, while other antidepressants may take weeks to work. The quick action is especially important for people in the midst of an immediate crisis struggling with suicidal thoughts.

Currently, however, depression is an off-label use for ketamine. It is also usually administered via an IV in specialized clinics. Thus, it has been difficult for people to access the drug. The small scale of ketamine treatment has also made it difficult to prove that the drug can really be effective for depression.

Johnson & Johnson's version of the drug, if it wins FDA approval, will apparently address these issues. Apart from being more practical as a nasal spray, J & J's version is based on the chemically similar esketamine. Esketamine, Johnson and Johnson hoped, would lead to fewer side effects such as sedation or dissociation, while still giving a similar antidepressant effect. The FDA also had hope related to the drug, giving it a breakthrough therapy term, a process that increases the assessment of a potential treatment for a serious or life-threatening condition.

It was not necessarily a given that J & Js drug would be recommended for approval, though. Out of the five Phase III clinical trials (the gold standard of evidence) presented, only two studies showed that esketamine performed better than a placebo. One of these trials involved adults younger than 65 who received flexible doses of the drug; the other was a randomized withdrawal attempt, in which volunteers were selected randomly to dispense with the drug or continue treatment (in all trials, patients took at least one other antidepressant). Most antidepressants approved by the FDA discovered the panel, had evidence from at least two or more Phase III studies, not including a randomized withdrawal test.

Finally, the 1

7-member panel voted overwhelmingly for approval, with 14 votes yes, two no, and one abstaining from voting. To explain its reasons, panel member Walter Dunn, a professor of psychiatry at the University of California, Los Angeles and a psychiatrist at the VA, went so far to call the drug a "waste exchange" for depression.

A major factor that influenced many of the "yes" votes was the FDA's suggestion on how it would approve the drug if it did. In the trials, patients were more likely to experience side effects within two hours of a dose. So the FDA suggested that it would probably approve the drug to be taken only in certain healthcare, where patients could be monitored for two hours. The monitored doses will be part of a major "Risk Assessment and Reduction Strategy", or REMS, the program of the drug.

The dose of ketamine given for depression is usually much lower than what people use to become highly recreational. But doctors are still concerned about the risk of abuse, and point out that the patients become addicted to the drug. The limitations on how esketamine will be taken, the FDA said, would help prevent abuse. As suggested, esketamine will be given twice a week at a clinic the first four weeks along with another new oral antidepressant, so weekly for the next four. Afterwards, patients can stay on a weekly schedule, or switch to every other week, as long as necessary – but they will always receive the doses under supervision.

Panel members who voted yes and no emphasized the need for more research on the effects of the drug, even if it wins approval. Some evidence has shown that people who abuse or abuse ketamine can develop permanent brain damage. And while there was no evidence of this effect in the human or animal trials, many experts with a lack of research arose that would exclude the possibility that this or other serious health risk would occur with ketamine if it became an approved long-term alternative to depression.

Nevertheless, it now seems likely that J&J drugs will get approval from the FDA, which would make it the first new type of depression treatment approved by the agency for decades since Prozac's arrival in 1986 (and only the other drug ever approved for treatment-resistant depression, after approval of a combination olanzapine / fluoxetine pill in 2009). While the FDA is not required to follow the advice of its advisory committees, it has rarely decided for the past few years. A final decision on the substance's approval can come as soon as in March.


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