FDA Approves New Depression Treatment, Questions Remain About Safety

J&J nasal spray gets U.S. approval as first new type of anti-depressant in decades

It will be prescribed by doctors for use in conjunction with an oral antidepressant for patients who have tried other forms of antidepressants that have not benefited from them. "Also, it seems to work in 24 to 48 hours, so there's a very rapid resolution of symptoms".

The United States Food and Drugs Administration (FDA) have approved for sale a new nasal spray containing Esketamine for the management of treatment-resistantdepression.

The FDA has approved a new type of treatment for depression.

The drug's approval came after only one positive short-term phase III trial.

Esketamine seems to help alleviate depression by acting on the NMDA/glutamate receptor, which is different from more recently popular 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.

"This saved my life", Snow said.

She takes the drug every two weeks at her psychiatrist's office while reclining in a comfortable chair.

Since enrolling in a Spravato trial two years ago, Prothro says her depression has lifted and she's returned to hobbies she abandoned years ago, like gardening. However, it usually takes about 3-4 weeks for a drug to show its final impact on a patient.

Timothy B. Sullivan, MD, chair of psychiatry and behavioral science at Northwell Health at Staten Island University Hospital, echoes these thoughts: "There is a significant number of people who suffer from major depression who either respond partially or not well at all to the current available treatments".

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).

The decision comes after an FDA advisory panel recommended approval of the drug, Spravato, which is created to treat depression in patients who have not benefited from two or more antidepressants. Meanwhile, esketamine delivers results within hours or a few days. However, this does not provide a long term fix.

"This is going to bring in some standards, regulation and it's going to make it safer and more accessible to patients", said Levine, who serves as vice president of the American Society of Ketamine Physicians, a group representing doctors, nurses and others using ketamine for treating depression or other nonapproved uses.

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