With Janssen’s novel drug for treatment-resistant depression (TRD), ‘Spravato Nasal Spray (esketamine hydrochloride)’ failed to demonstrate efficacy in Japanese and Chinese patients, the Korean authorities also held discussions on whether to maintain its marketing authorization status in Korea as well. The drug was approved in June 2020.

As a result, the authorities decided that no immediate action such as suspension of sales should be taken as no results have shown that the drug was ineffective in Korea. However, the company will be required to submit Phase III clinical trial-level data to further prove its efficacy.

For now, the product has been kept on the shelves, but attention