Johnson & Johnson's Nasal Spray Antidepressant Gets Approved by the FDA

11:54 03/09/2019

Pharmaceutical giant Johnson & Johnson  JNJ  has received approval from the U.S. Food and Drug Administration for its nasal spray antidepressant Esketamine, for people who are resistant to other kinds of treatment.

Esketamine, which will have the brand name Spravato, is 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.

The FDA has put restrictions on the use of the drug and warned that it could be misused and abused. The FDA said that the nasal spray is for use in conjunction with an oral antidepressant in adults with treatment-resistant depression.

'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,' remarked 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, he added.

A key advantage of the nasal spray is that it can potentially help those experiencing suicide thoughts more quickly as it is fast-acting.

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