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In a huge gain for millions of patients suffering from treatment-resistant depression, the FDA has just approved a fast-acting drug that can be very effective for patients who do not respond to other treatments. The drug is esketamine – and its name sounds good because it is closely related to ketamine, a sedative used in veterinary medicine and, to a lesser extent, in humans.
Ketamine also has recreational uses not indicated on the labels. If you are wondering how a family member of this drug has been involved in the treatment of depression, you are probably not alone.
Researchers have experimented with ketamine to treat depression in limited trials, where it has been shown to be extremely effective in some patients. These clinical trials have focused on ketamine infusions in a clinical setting where patients can be monitored.
To participate in clinical trials, patients had a history of drug-resistant depression in which they did not respond to at least two different antidepressants. Many patients try a multitude of medications and treatment options before they are diagnosed with treatment-resistant depression. Some people may even explore modalities such as transcranial magnetic stimulation or electroconvulsive therapy, which can also be very effective.
For patients suffering from treatment-resistant depression, staying alive can be a constant struggle. If the symptoms of depression differ from person to person, this condition can be life threatening – not just because of the risk of suicide. People with severe depression may have difficulty with activities of daily living, including taking care of themselves and remembering to eat. Repeatedly trying out non-functioning treatment modalities can also add to the distress, as well as knowing that a method works, but only temporarily.
Ketamine treatment does not work in all patients, of course, and the duration of effectiveness is variable. However, any new advances in the management of mental illness deserve to be celebrated. The esketamine – supplied under the brand name Spravato – will be available in the form of a nasal spray, which will make it much easier and safer to administer.
However, it will still be administered in a clinical setting because of recreational associations with ketamine and concerns about the side effects of this medication, which may include dissociation and sedation. Patients will need to visit a clinic for treatment and at least two hours of supervision before they can be released.
Although these precautions increase the costs and difficulties of access to treatment, the FDA believes that this is justified given the risks of abuse. Hopefully, the more drugs that are accepted, the easier it will be to find providers who offer them.
Patients should also continue taking an oral antidepressant and may be advised to take additional treatment and continue treatment depending on the specificities of their case. Although this fast-acting drug can help patients, long-term, stable monitoring and care is also essential.
It will also be possible to continue to have access to ketamine for the treatment of depression, as doctors can legally prescribe it for non-label uses – and a nasal spray formulation is also available. Initially, Spravato will be extremely expensive, a consideration for patients with limited insurance coverage. It is also less potent than ketamine, a consideration for some doctors who might want a more potent drug for their patients.
This FDA approval should also help normalize treatment with drugs in the ketamine family, a concern for patients and doctors who see results with ketamine but feel judged for the use of a drug that most people consider it recreational.
Ketamine is not the first drug for therapeutic or recreational use, and research on the benefits of medications falling into this category is a big win for patients who have trouble finding and paying for care for ailments that could prevent treatment in a conventional way.
Photo credit: Getty Images
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