FDA Approves Ketamine-Based Nasal Drug That Can Treat Depression; Could Help Millions

FDA Approves Ketamine-Based Nasal Drug That Can Treat Depression; Could Help Millions

A patient who uses esketamine could feel better in hours, or days, unlike regular antidepressants, where it takes months to see a slight difference

There are over 16 million Americans who live with depression, of which around 25 percent of them never gain any respite from depression, either through treatment or medication, according to The New York Times. But, there may be a solution for them, too, as the Food and Drug Administration approved a prescription treatment intended to be a fast relief medication, and it's been derived from a drug called ketamine which is an old and widely used anesthetic. The newly approved drug, called esketamine, is said to be injected and consumed as a nasal spray that's being developed by Janssen Pharmaceuticals Inc. (which is a branch of Johnson & Johnson).


The nasal spray will be marketed under the name Spravato, and it will contain an active portion of the ketamine molecule, but the antidepressant properties of ketamine are not completely understood yet.  “Thank goodness we now have something with a different mechanism of action than previous antidepressants,” said Dr. Erick Turner, a former F.D.A. reviewer and an associate professor of psychiatry at Oregon Health & Science University.


“But I’m skeptical of the hype because in this world it’s like Lucy holding the football for Charlie Brown: Each time we get our hopes up, the football gets pulled away,” he added. Ketamine is already in use for depression as it is available at hundreds of clinics around the country, where intravenous treatments are provided. Studies actually suggest this method can help people who are treatment resistant, even though it's sometimes said to out-of-body and hallucinogenic sensations when administered.


Ketamine was used (and a very popular one at that) as a club drug, known as the Special K, during the 1980s and 1990s. Treating depression with intravenous ketamine is quite a costly affair as it is not approved by the FDA for depression, but in contrast, esketamine is likely to be covered under many insurance plans. Even though the nasal spray will have side effects similar to that of generic ketamine, it is assumed to be less dramatic.


The newly approved drug is said to be taken twice a week, for four weeks, combined with boosters as needed, along with one oral antidepressant that's used commonly. According to the FDA, the doses of esketamine are required to be taken in a doctor's clinic or office where the patients can be monitored for at least two hours, so their experience can be entered in a register. Patients have been strictly warned not to drive on the day of the treatment.  Just like ketamine, esketamine, too, has the potential for abuse and it can induce psychotic episodes. 


The cost comes between $4,720 and $6,785 for a one-month treatment, said Janssen. By approving esketamine, it shows how serious mood problems are being taken into consideration and a new approach is being used. Prozac and other similar drugs basically enhance the brain messengers and increase their activity, like serotonin, but they are mildly effective. So it takes weeks, or even months, for its effect to be felt. Which is why, for many patients, these drugs provide little or no relief from depression. 


Compared to these, ketamine-based medicine is said to work within hours, or days, and will even be effective in some people who are considered to be resistant to treatment from other antidepressants. “These are exciting times, for sure. We have drugs that work rapidly to treat a very severe illness," said Dr. Todd Gould, an associate professor of psychiatry at the University of Maryland School of Medicine. Dr. Gould has identified a breakdown product of ketamine that could be developed into another drug. 


Experts seemed to be a bit wary of the drug, and the esketamine trials by Janssen also came out to have mixed results. In each of the trial, the patients were all started on an antidepressant drug, and given a placebo or a course of esketamine. In one study that lasted for a month, those who were given esketamine performed better than those on placebo. But in two other trials, ketamine did not have better results than the placebo treatment.


The FDA has maintained that a drug succeeds in two trials before it is approved, but they loosened their reins a bit with esketamine. “We’ve had nothing new in 30 years. So if this drug is an effective way to get a more rapid response in people who are treatment resistant, and we can use it safely, then it could be a godsend," said Steven Hollon, a professor of psychiatry and behavior sciences at Vanderbilt University. 


Disclaimer : This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

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