FDA Approves Medication for Treatment-Resistant Depression

Spravato Can Relieve Depression-Like Symptoms in Just a Few Hours

On Tuesday, March 5^th, the Food and Drug Administration officially approved a new nasal spray medication known as Spravato (Esketamine) for treating depression-like symptoms. Produced by Johnson & Johnson, the drug is targeted towards patients that have tried other antidepressants in the past but did not see a noticeable improvement. Unlike most antidepressants, Spravato can relieve depression-like symptoms in just a few hours instead of several weeks. It’s based on the drug known as ketamine, which is often associated with clubbing and drug abuse.

As Spravato makes its way into the healthcare system, the FDA and care providers are doing everything they can to prevent misuse of the drug. Learn more about Spravato and why it’s considered a potential “game changer for millions of people”.

What Is Spravato?

Spravato represents the first breakthrough in antidepressants in over thirty years since Prozac first hit the market back in 1988. Instead of swallowing a pill, patients will inhale the drug through their nose. Spravato has been shown to reduce depression-like symptoms in just a few hours, such as fatigue, anxiety, irritability, insomnia, and mood swings. Unlike oral antidepressants like Prozac that target the brain’s serotonin system, Spravato targets the brain’s glutamine system.

According to the FDA, Spravato was evaluated over the course three short-term (four-week) clinical trials and one longer-term maintenance-of-effect trial. Due to the serious nature of depression, patients that participated in the clinical trials were also given an oral antidepressant. Patients were either given Spravato or a placebo nasal spray. In one short-term trail, patients using Spravato and an oral antidepressant saw the severity of their depression reduced more so than patients taking the placebo nasal spray and an oral antidepressant. In the longer trail, patients using Spravato and an oral antidepressant saw their depressive symptoms relapse less often than patients on placebo nasal spray plus an oral antidepressant.

Common side-effects experienced by patients treated with Spravato in the clinical trials include disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.

Why It’s Considered a Potential “Game Changer”

Spravato may not work for everyone and it’s specifically designed for patients with treatment-resistant depression. Many patients struggling with depression do not benefit from oral antidepressants like Prozac. According to officials from Johnson & Johnson, there are 16 million people living in the U.S. with major depression and 5 million of these people may benefit from Spravato as a way of treating their symptoms where other antidepressants were shown to be ineffective.

Patients using Spravato may also see results in just a few hours as opposed to several weeks. Many patients suffering from depression struggle with thoughts of suicide among other symptoms, so finding fast relief from these symptoms is essential. Healthcare providers will also know if Spravato is effective within just a few days instead of having to wait several weeks before adjusting a patient’s treatment regimen.

Abuse Considerations for Spravato

Spravato is not for everyone. It’s only for patients with a major depressive disorder that have tried at least two antidepressants, given at adequate doses, in the past without seeing a noticeable improvement in their symptoms. Patients must come to an authorized treatment center to receive the drug and they won’t be allowed to take it home. Patients may only inhale the drug with doctor supervision once or twice a week. They must also be supervised by a doctor for at least two hours after inhaling the drug. Patients may not drive or operate heavy machinery after receiving Spravato and must make arrangements to leave the treatment center safety.

Again, Spravato is based on the drug known as ketamine, or Special K, which is often considered a party drug. With high doses, it can lead to out-of-body experiences, sedation, and hallucinations. With these risk factors in mind, the FDA and Johnson & Johnson are doing everything they can to help care providers prevent misuse. Spravato will be accompanied by a warning label, stating patients “are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug.”

Spravato could benefit millions of patients with a major depressive disorder that have tried other antidepressants in the past with little success. As promising as this new drug may seem, care providers need to make sure they are dispensing the drug safely and following the FDA’s proper use guidelines to avoid possible issues of addiction and drug abuse. Hopefully, more patients will find the relief they’ve been looking for as Spravato becomes more readily available.