A New Promising Drug for Treatment-Resistant Depression: Approved by FDA


March 2019 /Psych ZenHealth

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A new drug named Esketamine was just approved by FDA and will soon be available in the market. Esketamine is derived from anesthetic Ketamine which is use for treatment-resistant depression—a depression that fails to respond to more than one antidepressant therapy. This is the first antidepressant drug that has a new mechanism of action. It works through the brain’s glutamate pathways- which may provide a faster onset of action and efficacy. The patient can start to see improvement of symptoms in a few hours, as opposed to days or weeks, and it can also maintain remission.

Ketamine is typically infused intravenously, which is not approved by FDA for depression, meaning it is not covered by insurance. However, some clinics offer off-label use of IV Ketamine infusion, and may cost between $400 and $2000 per infusion, depending on the provider, location, ketamine dose, and the condition being treated.

Esketamine is officially approved by FDA and is delivered to patients via intranasal spray. It will be given in conjunction with oral antidepressant to supplement the medications weekly or bi-weekly dosing.

Ketamine is known as a street drug and has a potential for abuse. It cannot be prescribed for patients to take home, instead it is given in the doctor’s office. Ketamine is a short-acting drug- means it typically have an effect between 2-4 hours. Patient will be under observation for few hours and will be monitored for potential side effects such as hallucination, sedation, dissociation, euphoria and increase blood pressure. The patient taking the drug will not be allowed to drive until the day after the treatment. All patients must be well informed about the benefits and risks of the drug before starting the therapy.

Given its effectiveness and the proposed risk evaluation, the benefits outweigh the risks of Esketamine for the treatment of depression that does not respond to other treatments. Esketamine is expected to be accessible to the public soon, and it will be marketed under the brand name Spravato. The manufacturer has placed an important restriction on the drug. Esketamine will be given only in an approved clinic or health center and will be administered by a provider trained in the therapy. This drug will not be available at a local pharmacy and not granted for take-home use.

Although this drug was approved only for treatment-resistant depression, Esketamine is also being considered by FDA as a prospective drug for patients with imminent risk of suicide.