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FDA Approves Ketamine Nasal Spray for Treatment-Refractory Depression

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On Tuesday, the U.S. Food and Drug Administration (FDA) approved the ketamine-based nasal spray esketamine (brand name Spravato) for treating refractory depression. The drug, which was developed by Janssen Research & Development, is the first major mental health drug treatment breakthrough in decades.

Esketamine — a “chemical cousin” to ketamine — works on the brain differently than existing antidepressants. Most long-standing mental health drugs target your monoamine system, including the neurotransmitters serotonin, dopamine and noradrenaline. Esketamine (like ketamine) seems to inhibit the glutamate receptor N-methyl-D-aspartate (NMDA), which has an anesthetic or dissociative effect and works as an effective antidepressant for some people. Instead of taking weeks to have an effect, ketamine-based drugs also seem to work much sooner, which may provide faster relief for those with refractory depression.

Janssen — the drug arm of the company Johnson & Johnson — introduced esketamine in September 2018. It was given “breakthrough” and “fast track” status by the FDA, which fast-tracked its progress through the drug approval system. On Feb. 12 an FDA advisory panel recommended approval of the nasal spray treatment based on two effective clinical trials with an acceptable safety profile when esketamine is used along with a traditional antidepressant.

However, of the four clinical trials submitted to the FDA for the spray’s approval, including three short-term and one longer-term clinical trial, only one of the short-term trials showed esketamine to have a statistically significant effect compared to the placebo. According to the FDA, “the two other short-term trials did not meet the pre-specified statistical tests for demonstrating effectiveness.” Esketamine then went to the FDA for official approval, which was granted.

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research in a statement, adding:

Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. Because of saftey concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient.

Esketamine won’t be administered like other mental health drugs and it is prescribed in tandem with a traditional antidepressant medication. Courtney Billington, president of Janssen Neuroscience, told NPR that if you’re prescribed esketamine, you won’t get it to take home — it will be given at approved treatment centers only. In the statement announcing its approval the FDA outlined the guidelines further — you’ll need to stay in the doctor’s office after each dose for at least two hours to make sure you’re safe.

Potential side effects and risks include sedation or dissociation, dizziness, nausea, decreased feeling or sensitivity, anxiety, lethargy, increased blood pressure and feeling drunk. Esketamine may also increase your risk for suicidal thoughts and, like ketamine, has a higher risk of misuse. In addition, esketamine has not been studied for its risks or benefits long-term — current clinical trials have not extended beyond 60 weeks.

According to Inverse, the cost of esketamine is between $590 and $885 a session for clinics, meaning the cost to patients will be different. Treatments occur twice per week, putting the first month’s cost for esketamine between $4,720 to $6,785. Patients will also have to factor in the costs of monitoring and the regular antidepressant medication they must take along with esketamine. These costs are without insurance. Insurance coverage for the drug will vary, and Janssen’s website offers some patients the opportunity to apply for a savings program.

Janssen is the first to bring a ketamine-related drug to the market, and drug companies Allergan and VistaGen are also developing ketamine treatments for depression. If you want to ask your doctor about trying esketamine, you can search for a certified center on the Spravato website.

Updated Oct. 16, 2019

Header image via vadimguzhva/Getty Images.

Originally published: March 6, 2019
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