SPRAVATO, First New Depression Medication in 30 Years, Approved by FDA

by Cooper Smith | |  

The Benefits of Spravato

In a historic vote, the FDA has approved Janssen Pharmaceutical’s new medication, Spravato™, for clinical depression. This is the first time that esketamine, a chemical cousin of ketamine, has been approved for medicinal use. The 14-2 vote, with one abstained, provides new hope for people suffering from depression.

The last medication to be approved for depression was Prozac®, over 30 years ago. The problem in waiting so many years to approve new medication is that some cases of depression are resistant to certain medications.

Spravato must be administered by either a doctor or under supervision, and only after someone has tried other depression medications. This is due to its potency and potential hazards.

The Spravato labeling contains a Boxed Warning that cautions that 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.

- FDA, 2019

Spravato is only meant for people who have had no success with prior medications. This is due to the nature of its primary component, esketamine. Esketamine gets its name from being chemically similar to ketamine, a potent hallucinogen and “club drug.” Ketamine was first created as an anesthetic for animals but was soon discovered to cause hallucinations when taken in large doses. This is what propelled its use as a club drug.  For this reason, Spravato will not be available over-the-counter and can only be administered under supervision.

While the FDA has approved it, keep in mind that there have been 6 reported deaths of people using Spravato, 3 of which were suicides. An investigation has ruled that the medication was not responsible for these deaths. Still, it shows that this is not a miracle cure and should only be taken under supervision and at the discretion of a medical professional.

The Risk of Spravato

Because of the risk of Spravato, patients who are given the medication must be monitored for at least two hours after taking it. It could be dangerous to drive or even walk home after the spray has been administered. If you or someone you love suffer from clinical depression, and other medications have failed in the past, talk with a doctor about Spravato. Do not, however, use it irresponsibly. It is a potent drug that could become hazardous when used incorrectly.

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