The FDA concludes the drug is also being tested in patients with depression who are at a high risk of committing suicide. He also is named as co-inventor on patents filed by the Icahn School of Medicine relating to the treatment for treatment-resistant depression, suicidal ideation and other disorders.
"Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA's drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment", added Farchione.
Esketamine is a departure from Prozac-era of antidepressants.
The FDA approved Spravato, known chemically as esketamine, based on study results that showed patients taking the drug experienced a bigger improvement in their depression levels than patients taking a sham treatment, when measured with a psychiatric questionnaire.
Hough said patients would receive the treatment two times a week for a month, then every week and then every other week, along with an oral antidepressant.
But esketamine presents some challenges because of its similarities to ketamine.
The drug is created to be lower-dose and easier to use than ketamine, which is normally given as an intravenous infusion.
Nevertheless, many hope that this new treatment will be a step in the right direction for mental health in the United States.
"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University.
"This is an exciting development and the first novel mechanism that goes beyond the current serotonin treatments", Dr. Sanjay Mathew of the Anxiety and Depression Association of America said in an interview.
Unlike ketamine, psilocybin and MDMA have no legal medical use. Ask your doctor for more information.
Spravato, which is administered via a nasal spray, is the first FDA-approved antidepressant in over 30 years.
The FDA is requiring patients who are prescribed the drug to be monitored closely, due to the possibility of negative reactions of sedation and disassociation tied to the drug.
Johnson & Johnson said the wholesale cost of each treatment with ketamine will range from $590 to $885, depending on the dose.
The Food and Drug Administration on Tuesday cleared the inhalable drug for patients who have failed to find relief with older antidepressants. These clinics often administer the drug in an intravenous infusion that can cost more than $500 per treatment.
The list price of a drug is not necessarily what patients actually pay.
Some doctors plan to offer both ketamine and the new J&J drug.