FDA Approves Fast-Acting Nasal Inhaler Depression Drug


Spravato is the first new anti-depressant to hit the USA market since Prozac in 1988.

Johnson & Johnson has received the U.S. Food and Drug Administration's approval for its modern-day anti-depressant nasal spray.

Esketamine is the S-enantiomer of ketamine, an FDA-approved anesthetic and a street drug called Special K which is known for its dissociative and hallucinogenic effects.

"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

The nasal spray must be taken by patients under the supervision of a healthcare provider in a certified doctor's office or clinic and the spray can not be taken home.

The approval is in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them.

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According to Janssen, treatment costs will depend on dosage and range from $590 to $885 per treatment session. Those drugs target the feel-good brain chemical serotonin, and can take weeks or months to kick in. The company announced that it was going to close down its 87 USA pop-up stores which showcased devices like its Echo, Kindles and other new products. It works nearly immediately.

Its swift action "is a huge thing because depressed patients are very disabled and suffer enormously", John Mann, a psychiatrist and researcher at Columbia University, tells The Associated Press. The drug is created to start working in hours instead of weeks.

New Brunswick, New Jersey-based Johnson & Johnson's Janssen subsidiary announced the approval of Spravato (esketamine), a nasal spray, for treatment of major depressive disorder in patients who have failed on treatment with other antidepressants. Esketamine and ketamine work by targeting glutamate, unlike now used antidepressants that target serotonin, and doctors were already using ketamine off-label to treat depression, according to the AP. A decade ago, he noted, companies began to abandon the effort.

Two of the other three short-term trials did not meet pre-determined statistical tests for effectiveness. Whether a patient stays on the drug for more than six months or a year will be up to the patient and his or her doctor, he said. "I close my eyes and my mind is amazingly quiet". Still, ketamine has always been explored as a potential treatment for depression due to its ability to relieve symptoms within hours. Classified in the same category as heroin and LSD, they are tightly restricted by the federal government.

Now available anti-depressants such as Eli Lilly and Co's Prozac work on neurotransmitters like serotonin and norepinephrine, but most drugs take at least four weeks to show effect and fail to produce an adequate response in about 30 percent to 40 percent of patients with major depressive disorder (MDD). Because of this, patient are required to be monitored by a health care professional for at least two hours after Spravato is administered and will be used in connection with an oral antidepressant, the FDA said. It is claimed to lift the mood of the patient within 24 hours of use. But J&J will face competition in the marketplace.

Doctors say it's basically the name-brand version Ketamine. Long term safety of the drug is also unknown yet. Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months.