Johnson & Johnson Gets Approval from FDA for Nasal Spray Antidepressant

It was a day of celebration for Johnson & Johnson on Tuesday after the pharmaceutical giant received approval from the U.S. Food & Drug Administration for its nasal spray antidepressant for people who are resistant to other treatments.

The FDA did however put restrictions on the use of th edrug and warned that it could be misused and abused.

The spray, called Esketamine, is the first new type of treatment for depression in over three decades. It will be sold under the brand name Spravato.

Spravato is a chemically like anesthetic ketamine, better known as Special K, a recreational party drug. The drug will have to be taken by patients in a doctor’s office or medical facility and they cannot take it home.

“Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, the global head of J&J’s Janssen Research & Development.

“Depression is a common and potentially debilitating illness that can have profound emotional, functional and economic impact on both those who suffer and their loved ones. The impact of depression is greatest for those who do not benefit from standard treatments,” said Michael E. Thase,* M.D., a professor of psychiatry and director of the Mood and Anxiety Disorders Treatment and Research Program in the Perelman School of Medicine at the University of Pennsylvania.

Thase served as a site principal investigator for the clinical trials.

“In Phase 3 clinical trials, we saw this therapy provide sustained improvement to patients with treatment-resistant depression.”

Disclaimer: We have no position in Johnson & Johnson (NYSE: JNJ) and have not been compensated for this article