FDA Approves Johnson & Johnson’s Ketamine-Derived Drug For Treatment-Resistant Depression

Insurance companies would not pay for an unapproved treatment

The U.S. Food & Drug Administration Tuesday approved Johnson & Johnson’s ketamine-derived nasal spray Spravato for treatment-resistant depression. The green light means ketamine—an anesthetic abused as a party drug but promoted by some doctors without FDA approval as a necessary treatment for the most severely depressed patients—has spawned the first materially new depression treatment in decades.

Following early research by the National Institutes of Health, specialized clinics have offered intravenous ketamine treatments for depression on an off-label basis for many years. But since insurance companies would not pay for an unapproved treatment and psychiatrists are not accustomed to giving patients IV infusions in their offices, Johnson & Johnson began developing and running clinical trials on a related molecule, esketamine, that could receive a new FDA approval and be given to patients more conveniently.

https://www.forbes.com/

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