FDA Approves Nasal Spray Depression Treatment With Serious Safety Questions Remaining

Mar 8, 2019 | Challenging Pharma, CNS, Depression, FDA Approval, Ketamine, Pharma Watch

The FDA recently approved the treatment of esketamine for depression. WBUR reports that the new approved drug contains an compound called ketamine, sold under the brand name Ketalar; it is a powerful medication used for anesthesia. It induces a trance-like state while providing pain relief, sedation and memory loss. Esketamine (Spravato) an enantiomer of ketamine, is used as an antidepressant nasal spray for treatment-resistant depression. Common side effects include psychological reactions as the medication wears off. These reactions may include agitation, confusion, or hallucinations. Elevated blood pressure and muscle tremors are relatively common, while low blood pressure and a decrease in breathing are less so. Spasms of the larynx may rarely occur. Ketamine is an NMDA receptor antagonist but it may also have other activity.  

The maker, Janssen Pharmaceuticals (a unit of Johnson & Johnson), is upbeat about the drug because its effects can be seen within several hours to days. Other antidepressants can take weeks or longer. Here & Now’s Jeremy Hobson speaks with Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai in New York. Charney has extensively researched ketamine and its use for depression.

Lead Research/Investigator

Dean Dennis Charney

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