FDA Approves, but Cautions, New Type of Anti-Depressant

The United States Food and Drug Administration approved, early this week, a new antidepressant medication in a nasal spray formulation, developed by Johnson & Johnson.  The medicine was conceived, specifically, to help patients who are resistant to other treatments but, as you can imagine, the FDA has put restrictions on it, warning that it has a higher misuse/abuse potential. 

This new medication is called esketamine and is the first new type of depression treatment to hit the market in more than three decades.  While it has certainly raised hopes that a fast-acting depression treatment may offer better relief for previously unreachable patients, it is has also raised concerns that it could be more dangerous. 

The danger, of course, is rooted in the fact that this medicine is chemically-similar to ketamine. While it would be sold under the brand name “Spravato,” this anesthetic is more commonly known as the street drug “Special K.” This means that one of the restrictions for approval is that the drug can only be taken in a medical facility; it will not be available for home use. 

Spravato is different than other anti-depressants in more ways than just its active ingredient. Prozac (Eli Lilly and Co’s brand name fluoxetine drug) is popular because it works on several neurotransmitters, particularly norepinephrine and serotonin.  While that makes it more effective than many other anti-depressants, these drugs can take four weeks before you start to feel their effect. More importantly, their efficacy is still only about 65 percent of total patients who have major depressive disorder. 

What patients need, then, is a medication that is not only effective consistently, but immediately as well.  As a nasal spray, Spravato is quickly absorbed into the blood stream, which can escalate efficacy for a newly prescribed oral antidepressant.  Drug trials have shown that Spravato can effectively relieve depression symptoms in as little as 24 hours, in some patients. 

FDA Center for Drug Evaluation and Research acting director, Tiffany Farchione, MD, explains, “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition. 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.”

It is important to remember, though, that much of this is preliminary.  It is currently being tested in depression patients who are at high risk for suicide. Furthermore, the FDA continues to warn that this particular drug puts anyone at higher risk for sedation, disassociation, and hypertension. 

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