Previously, the drug, Spravato, was only approved for people with treatment-resistant depression. Now people with major depressive disorder with acute suicidal ideation or behavior will be allowed to take the drug.
Spravato, a fast-acting nasal spray, is the first treatment shown to reduce symptoms of depression within 24 hours, J&J said.
The drug is designed to act within hours, rather than the weeks or months other antidepressants take, but its inclusion of ketamine, known as Special K, which was once a popular party drug, has sparked concern that it may be abused.
In response to abuse concerns, the FDA put restrictions on Spravato’s approval. The drug is only available at a physician’s office or clinic, and patients must be monitored by a healthcare provider for at least two hours after taking it.
Last August, President Donald Trump instructed the Department of Veterans Affairs to make a large purchase of the drug to curb veteran suicides, and by March, only 15 veterans had been treated with the drug.
Spravato has been criticized by experts because of questionable clinical trial results. In one trial, six people taking the drug died, three by sucide, while no deaths took place in the placebo group. The clinical benefits of the drug have been questioned by experts, as it barely met the FDA’s threshold for being statistically significant.
Many mental health experts have raised concerns about the COVID-19 pandemic exacerbating mental health issues or introducing new ones in patients, according to Bloomberg. The rate of suicides in the U.S. rose 30 percent between 1999 and 2016.
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