Published: Tue, March 12, 2019
Health Care | By Cedric Leonard

FDA approves new nasal spray medication for depression

FDA approves new nasal spray medication for depression

There's a new ally in the ongoing battle against depression that doctors say works faster and more efficiently than previous drugs.

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.

Prozac therapy can take weeks or months to become effective, but Spravato has an nearly immediate effect as it alters the neurotransmitter glutamate, according to researchers. But the FDA approval, he adds, is a step toward having another viable and safe treatment for major depression. The medication will be marketed under the name Spravato.

Due to the high potential risk of misuse of the drug, Spravato will only be available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).

"There has been a longstanding need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Dr. Tiffany Farchione, acting director of the FDA's Division of Psychiatry Products.

Patients can only receive Spravato under the supervision of a health care provider at a certified clinic, who is required to monitor treated individuals for at least two hours after administration.

The drug comes in the form of esketamine, a mirror image of the ketamine molecule, which is far more potent.

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The approval of J&J's modern-day anti-depressant nasal spray marks the first advanced treatment innovated for fighting depression in decades.

Two of the other three short-term trials did not meet pre-determined statistical tests for effectiveness.

A long term study of the drug showed that patients in stable remission taking the drug that continued the treatment were 51 percent less likely to relapse as compared to those who continuously took a placebo with an oral antidepressant. In a recent interview with Scientific American, Dr. Erick Turner, a psychiatrist at Oregon Health and Science University, said the drug had undergone only one government-supervised trial and needed a second.

A clinical trial patient known as Robin P said the drug had a positive impact on him.

The pharma said it was working to educate and certify treatment centers for Spravato.

According to Janssen, treatment costs will depend on dosage and range from $590 to $885 per treatment session. He has researched ketamine and used it to treat depression. At two sessions a week, the cost is upwards of $4,720 in the first month. Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months.

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