FDA approval of ketamine spray signals ‘major shift’ in depression therapy

It is ‘quite likely’ the TGA will approve the drug to treat resistant depression in Australia, says psychiatrist
Lydia Hales
Ketamine formula

The approval by the US Food and Drug Administration of a ketamine-like nasal spray for treatment-­resistant depression has been described as a paradigm shift by a leading Australian psychiatrist.

Last week the US regulator gave the green light to Spravato, which contains the ketamine derivative esketa­mine, following several short trials that included Australian patients.

US patients with resistant depression will only be able to use the drug in conjunction with an oral antidepressant and under strict conditions — ­including being monitored by a doctor for two hours after administration in case of serious reactions such as elevated blood pressure or dissociation.

Professor Colleen Loo, a psychiatrist and ketamine researcher from UNSW Sydney’s Black Dog Institute, says the decision is a sign of growing acceptance of the drug as a therapeutic option.