FDA approves new Johnson & Johnson drug for depression

Leslie Hanson
March 10, 2019

Unlike recreational use of ketamine, Spravato will be delivered via a nasal spray under extremely close observation.

The US Food and Drug Administration (FDA) approved Spravato (esketamine), a nasal spray created by Janssen, a subsidiary of Johnson & Johnson, for treatment-resistant depression in conjunction with an oral antidepressant.

"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. All combinations of antidepressants and esketamine were administered in patients who suffer from treatment-resistant depression. A health care provider will monitor the patient until it is clear they are ready to leave.

Nevertheless, many hope that this new treatment will be a step in the right direction for mental health in the United States.

This approval comes shortly after the US FDA Psychopharmacologic Drug Advisory Committee recommended Spravato for approval based on its benefit-risk profile. These medications can lead to psychotic episodes in those at high risk, but advocates are hopeful that Spravato can relieve the symptoms of depression in the most desperate patients, according to the article.

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

The drug was first developed and approved by the FDA to be used in surgeries in 1962, as a safer alternative to the anesthetic phencyclidine, AKA PCP.

The effectiveness of the previous class of antidepressants, like Prozac and Paxil, was wildly exaggerated when they first hit the market, and the results of esketamine trials, which were paid for by the Johnson & Johnson affiliate, have been mixed. The FDA granted the drug both "Fast Track" and "Breakthrough Therapy" designations.

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