Promising new drug against treatment-resistant depression – esketamine

Treatment-resistant depression affects 1 in 3 of the estimated 16.2 million adults in the United States who have experienced at least one major depressive episode. For them, two or more therapies have failed and the risk of suicide is much greater. This is a bad prognosis.

Since there are few treatment-resistant treatments for depression, the Food and Drug Administration has considered a new treatment called esketamine. On February 12, 2019, I participated in the review of this drug by the FDA. In practice, esketamine is essentially the same as ketamine, an badgesic with hallucinogenic effects and used illegally. As a member of the FDA's Drug Safety Advisory Committee and Risk Management, I voted with the majority of this group 14-2 to approve esketamine only for people suffering from drug-resistant depression.

For more than 20 years, I've studied illegal drug use and addiction. As a medical anthropologist, my job is to understand the perspectives and behaviors of people who are actively using illegal drugs. My research often involves field work, which involves participating in people's daily lives. This has given me a personalized and practical vision of illicit drug use. Of the people I currently meet, many are heroin injection users who have started taking opioids by misusing prescription drugs.

Not a street drug

But many drugs, especially those for the treatment of mental illness, have powerful effects on the central nervous system. How the medicine is distributed and administered should minimize the risks. And if the drug is addictive?

Some reports on esketamine caused a stir in this regard by referring to ketamine as a highly addictive street drug. In my research, this is not true. First, the consumption of ketamine is rare. The last time I interviewed a ketamine user, it was almost 20 years ago and, since its introduction in 1964, there has been no trend or trend. significant epidemic in its diversion or use.

All illicit drugs are not sold "on the street". Illicit drugs are an essential part of the illegal drug economy, which is run by drug trafficking organizations. Prescription opioids, heroin, cocaine and marijuana are illicit drugs sold in the open-air drug markets, where such markets exist. Hallucinogens and exotic drugs, synthetic drugs and less popular drugs are rarely available in these environments. They simply do not appeal to enough users to make them profitable for drug traffickers. Ketamine has always been part of this second group. Why?

Is it addictive?

Ketamine has a short duration of action – between two and four hours – and produces euphoria, sustained pain relief and sedation, combined with powerful hallucinogenic effects. Taking this medicine can be very unpleasant. Out-of-body experiences, distortions of time perception, tunnel vision and dissociation are common. These effects limit the popularity of ketamine and make it difficult to use.

A person can take heroin everyday and work. Ketamine is disruptive.

Another reason why ketamine is not popular on the street is that users should not continue to use it to avoid withdrawals. There is no withdrawal syndrome badociated with ketamine; when people stop using it, they do not get sick. It is actually an advantage because the fear of withdrawal is often a major motivation for the continuation of drug use. Unlike illicit drugs, its appeal is limited and its dependency liability is relatively low.

Overall, the profile of ketamine is more like LSD than cocaine or opioids. People do not become addicted. This does not mean that ketamine or esketamine is safe. Access must be limited and use supervised by a physician. The manufacturer imposes significant restrictions on the drug. It will not be available at local pharmacies and will never be used at home. A person receiving the treatment, developed by Johnson & Johnson and administered as a nasal spray, will be monitored and managed by a trained health care professional. The drug will be administered in an office or approved health center and the patient will not be allowed to drive until the day after treatment.

Given its effectiveness and the proposed risk badessment and mitigation strategy, the benefits outweigh the risks badociated with esketamine for the treatment of depression. having not responded to other treatments. As with any new treatment, when manufacturers make this product available, it will be important to control that the benefits outweigh the costs. People living with depression due to treatment-refractory depression need more options, and this medication should help them.