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Why the new FDA approved nasal spray esketamine is a big deal



If you have not found an antidepressant that works for you, there may be hope for the first time in 30 years: The FDA has just approved a new ketamine-based drug that helps with treatment-resistant depression.

The New Drugs – a nasal spray based on ketamine's chemical sibling esketamine – has two major selling points: for starters, it can help 30 to 40 percent of people with severe depression who were not lucky with other antidepressants.

How It Works

With other antidepressants on the market, "the difference from one type to another is a type of Coke to Pepsi," says Men's Health Adviser, Drew Ramsey, clinical assistant professor of psychiatry at the Columbia University. "But ketamine is like kombucha." While the majority of antidepressants on your monoamine system affect serotonin and epinephrine, ketamine instead binds GABA receptors completely, forms new nerve connections and stimulates brain growth.

The other reason why Esketamine is remarkable is that while you have to wait anywhere from four weeks to three months to see if something like Zoloft helps with depression (and if not, you'll have to start over from scratch again). ) With a new med) Ketamine can improve your mood within a few hours to a few days.

The news that ketamine helps depression is not new. Most people have used the drug for mood disorder for a decade, and there are ketamine clinics across the country where depressed patients can get the drug intravenously. The new drug is basically the same, but in a nasal spray, which means it contains no needles and is therefore less scary and less costly.

Esketamine, marketed under the name Spravato, must be administered by a psychiatrist (more about why that matters in a minute), and the effect of a dose takes about two to four weeks. It does not work for everyone ̵

1; Ramsey says it helps anywhere between 40 and 70 percent of people – but you'll know if it fits you after just one infusion, which greatly speeds up the search for effective treatment, he adds. If it is effective, seek an infusion once or twice a month instead of taking a pill daily.

Most people do not question the safety of esketamine for the right population. Despite its reputation as a club medicine, ketamine has been used as an anesthetic in hospitals for decades and the dose in the nasal spray is significantly lower than what people abuse.

The controversy

But the science behind drug efficacy is somewhat controversial – mostly because two out of five key studies failed to reach their primary endpoints.

There is an entire subgroup of people with treatment-resistant depression For whom this drug is not right – for those with psychotic symptoms for whom ketamine can exacerbate episodes, and for those with drug or alcohol abuse in the past.

Officially, the FDA cites sedation and peak blood pressure as major risks. But the biggest risk, Ramsey says, is that you essentially have a bad mini-trip. For esketamine to work, you need to experience dissociation or the feeling of detaching yourself from your thoughts, feelings or your sense of identity. Whether this is a pleasant, neutral, or unpleasant experience depends entirely on the person, explains Ramsey. It can take people from a few hours to a few days to recover from a negative infusion experience, but the effects are not long term, he assures.

Thomas Kosten, MD, Professor of Psychiatry and Pharmacology at Baylor College of Medicine, anticipates potential problems if the drug leaves clinical trials and enters the real world. "Most people do not have depression – many have a dual diagnosis with other symptoms and disorders, so if you have a poor diagnosis, ketamine can make psychotic symptoms worse," he explains. And there are concerns about the initial mood buzz that reduces the likelihood of long-term help if, for example, you get esketamine after a suicide attempt at the ER.

Ramsey does not deny that risks exist. "They give a patient with severe psychiatric problems a strong psychoactive drug. Is there a risk that something will go wrong? Of course. But that's why you put yourself in the hands of trained staff, "he says.

The fact that the drug has to be prescribed and administered by a clinician will usually help identify suitable candidates, minimize abuse, and make unpleasant dissociations less frightening. And regardless of these side effects, the reality is: For many who suffer from severe depression and do not find lasting relief from the available antidepressants, esketamine provides a recovery they would not otherwise have.

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