FDA approves nasal spray for treatment-resistant depression

Maricruz Casares
Марта 12, 2019

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. But the FDA approval, he adds, is a step toward having another viable and safe treatment for major depression.

Under the brand name Spravato, the drug (which has the chemical name esketamine) will be prescribed to adults who have tried other antidepressant medicines but not benefited from them. This is due to strong potential for abuse and misuse of the drug, as it contains a compound similar to street-drug ketamine.

The FDA will require J&J to track patients to better understand the drug's safety and effectiveness. Companies like Allergan Plc Sage and Therapeutics Inc. are also testing depression drugs that can work quickly.

Patients will then have to remain at the clinic for two hours after using the spray to be monitored by a professional "because of the risk of sedation and dissociation". Critics are anxious, however, that the drug will have a high potential for abuse, like its cousin ketamine. Recently, some doctors have used ketamine to treat the patients of depression without formal FDA approval.

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Patients with depression who have failed existing antidepressants have had few other treatment options.

In that trial, patients in stable remission on Spravato were 51% less likely to relapse compared to those who continued on a regimen of placebo plus 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. Spravato can't be taken at home. The first month of treatment can range in price from $4,720 to $6,785, with subsequent monthly costs ranging from $2,360 to $3,540 before insurance discounts and rebates. Spravato could be available within days at centers to complete the REMS certification. In a briefing document released ahead of the advisory committee meeting, members expressed concern that because patients in one of the trials receiving Spravato at 84mg did not experience greater efficacy than those receiving 56mg, there may be insufficient evidence to say the higher dose yields a therapeutic dose response relative to its higher rate of adverse side effects.

Charney was part of the team that first showed two decades ago that ketamine could treat depression. Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months.

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