J&J’s esketamine spray gets pivotal new approval

Aug. 3, 2020

Johnson & Johnson’s esketamine spray, Spravato, has become the first ever antidepressant approved to treat suicidal patients. According to the company, Spravato is now indicated in conjunction with an oral antidepressant to treat symptoms of major depression disorder (MDD) with acute suicidal ideation and behavior. 

J&J says Spravato is well-suited to treat suicidal patients because it is a fast-acting nasal spray, rather than a traditional antidepressant which can take weeks to start working.

When Spravato was approved in March 2019, it was the first new drug approved to treat depression in more than 30 years. It was also the first approved drug with esketamine, a chemical cousin to the “club drug,” ketamine, as its primary ingredient.

The drug was approved for this new indication even though a pair of late-stage studies showed that it did not have a statistically significant difference in reducing suicidal thinking than a placebo. 

Earlier studies of Spravato as an antidepressant were also mixed. Although some studies showed benefits when the drug was used in combination with a traditional SSRI antidepressant, Spravato failed two late-stage trials. In January, the UK’s national health system rejected coverage of Spravato, citing concerns about its effectiveness and cost. 

Read the Bloomberg report.