For those who have not responded positively to other antidepressants, the US Food and Drug Administration (FDA) will provide a new drug against depression. The government agency has just approved an esketamina-based nasal spray, part of the ketamine anesthetic molecule, which will therefore be the first fast-acting depression drug available on the American market.
However, immediately after the decision of the FDA, the opinions of the medical community were divided: some people willingly accepted the arrival of this new drug against depression and those who showed doubts and skepticism about the substance. According to these latter experts, in fact, the approval of the new drug would have taken place too quickly, not taking into account the high risk of substance abuse, also used as a drug with psychedelic effects.
Let us remember, in fact, that ketamine is indeed an anesthetic drug, also a heavy drug, and for this we must be cautious and warn about its potential abuse. The fact that esketamina is administered by means of a spray does not mean that it can be used independently by patients. In fact, the drug will only be available in certified clinics where doctors can monitor the patient, a move by the FDA to significantly reduce the risk of abuse and dependence. Moreover, the treatment will be anything but economic: a cycle, in fact, will cost about 7 thousand US dollars .
Unlike most of the antidepressants available today, which can take up to 4-6 weeks to show the desired effects, the new drug, developed by the pharmaceutical company Janssen, part of Johnson & Johnson, is able to act within a few hours and will be intended only for people who have already tried at least two other types of therapies, without however reporting any effect of improvement.
The clinical study conducted by Janssen and Yale School of Medicine showed on the pages The American Journal of Psychiatry, the magazine of the American Psychiatric Association, that the combination of this spray with an antidepressant can bring greater benefits, at a distance of 4 and 24 hours from the beginning of the therapy, compared to the use of the antidepressant alone.
The rapid action of this new drug comes from the fact that it works differently than traditional antidepressants, such as fluoxetine. In fact, the latter increases the presence of serotonin in the brain, an important substance in the regulation of sleep and mood, thus alleviating the symptoms of depression for some patients. Esketamina, however, takes aim at a different chemical called glutamate. More precisely, it is able to activate a glutamate receptor, the Ampa receptor, and it is hypothesised that this mechanism may have antidepressant actions.
However, the skepticism of the doctors about the approval of the FDA of the new drug was not long in coming. Although, in fact, some have shown themselves eager for a new treatment for depression, others, instead, have expressed concern that they have not put sufficient safeguards in place so that the drug can be administered responsibly.
“This is undeniably a big step forward”, he told the Washington Post Jeffrey Lieberman of Columbia University psychiatrist, pointing out that many other research should be done on the effects of the new drug (we point out that the side effects to now include dizziness, nausea, anxiety, lethargy, vomiting, feeling of drunkenness, decreased sensitivity, sedation and dissociation, the feeling of being temporarily “disconnected” from the body and mind), and in particular with regard to its long-term use. “The doctors will have to be very judicious in administering it,” the expert warned.
Finally, we recall that last October the request for approval of the nasal spray was presented also in Europe. We will therefore have to wait for the response of the European Medicines Agency (Ema) to be able to have the drug on our market too.