The Food and Drug Administration has approved a new nasal spray for the treatment of severe depression.
On Tuesday, the government agency announced Spravato nasal spray, also known as esketamine, can now be used “for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them.”
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in a statement.
The FDA said patients with major depressive disorder who have tried at least two antidepressants are considered to have treatment-resistant depression.
It is estimated that approximately one-third of U.S. adults with a major depressive disorder have treatment-resistant depression, according to Janssen Pharmaceutical Companies of Johnson & Johnson, which developed Spravato.
Spravato should be used in conjunction with an oral antidepressant, according to both the FDA and Janssen.
The FDA said this is the first time esketamine was approved for any use. The agency approved ketamine, a related drug and an anesthetic, in 1970.
Ketamine, also known as “Special K,” a party and date-rape drug, became a controlled substance in 1999.
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According to the FDA, Spravato’s label will contain a boxed warning cautioning “patients are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug.”
The most common side effects from the clinical trials were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.
The spray cannot be taken home and only can be administered in a certified doctor’s office or clinic, according to the FDA. Patients have to be monitored for “at least two hours” after receiving a dose and can’t drive for the rest of the day.
“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 Dr. Mathai Mammen, global head, Janssen Research & Development, LLC, in a statement.
In the company statement, Janssen said it would work quickly to educate and certify treatment centers, so health care providers could start offering Spravato.
Later this month, a locator tool will be posted at www.spravato.com, the drug’s future website, where patients will be able to sign up to receive alerts when new treatment centers are available. The website was not live as of Tuesday night.
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