The panel members echoed concerns raised by FDA staffers regarding the increased risk of sedation, dissociation and higher blood pressure observed in the study
An advisory panel to the US Food and Drug Administration voted in favour of Johnson & Johnson’s experimental nasal spray, which has a compound similar to often-abused ketamine, bringing the drug closer to approval. The panel voted 14-2 in favour of the drug esketamine, developed to treat major depression in patients who have not benefited from at least two different therapies, saying its benefits outweighed the risks. One panel member abstained from voting.
Esketamine is a chemical mirror image of anesthetic ketamine, which is also abused as a recreational party drug and goes by the street nickname ‘Special K.’ “I think esketamine has the potential to be a game-changer in the treatment of depression … I use the term potential because the issues of cost and patient accessibility need to be addressed,” said Walter Dunn, who voted in favour of approval. However, the panel members echoed concerns raised by FDA staffers regarding the increased risk of sedation, dissociation and higher blood pressure observed in the study.
The FDA recommended implementing a risk evaluation and mitigation strategy (REMS) programme which included ensuring esketamine is only dispensed and administered under supervision. “Ketamine is a nasty drug … should (J&J’s) drug get approved, I think a strong effort has to be given as part of REMS … so that patients really know what they are getting themselves into,” said Steven Meisel, another member who voted ‘yes’.
Major depressive disorder affects over 300 million people globally. About 30 per cent to 40 per cent of these patients fail to respond to first-line treatments such as antidepressants, most of which take at least four weeks to show effect. However, depression is a tricky area of development. Patients in clinical trials often show a big placebo response, masking the efficacy of the drug being tested. Currently, Eli Lilly and Co’s Symbyax is the only FDA-approved drug for treatment-resistant depression.
“There is a lot of potential for people that just want that quick fix. I really would be cautious,” said Kim Witczak, a panel member who voted ‘no’. J&J’s esketamine, used in combination with a newly prescribed antidepressant, works by restoring the nerve cell connections in the brain, leading to an improvement in depression symptoms. The FDA, although not mandated to follow the panel’s recommendation, is expected to announce its decision on esketamine by March 4.