(Un)Treatable

Once a club drug of a bygone era, ketamine has found a new lease of life as an FDA-approved treatment for treatment-resistant depression. According to the WHO, depression is the leading cause of disability worldwide (1). Treatment-resistant depression (TRD; a failure to respond to two different types of antidepressant at an adequate dose and sufficient period of time) affects 50 percent of all patients with depression and carries an increased risk of suicide (2).

In September of 2018, Janssen announced its New Drug Application (NDA) to the FDA for the approval of a novel esketamine-based nasal spray for the treatment of TRD last year - and in February the drug was recommended for approval by the FDA’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee (3). 

The drug will be used alongside conventional oral antidepressants. 

“We decided to pursue development of an enantiomer - or one side of the ketamine molecule - because it could be formulated as an intranasal medicine (nasal spray), thus potentially allowing appropriate patients in need to have access to it,” a spokesperson from Janssen explained.

Though the mechanism of action of ketamine is not completely understood, it is thought that the drug acts upon the glutamate system allowing brain cells (neurons) to reconnect, thus improving synaptic plasticity (the efficiency of information transfer through synapses – the junctions between neurons). Though there were delays in the approval process due to the US government shutdown, Janssen has already filed for approval in the EU and intends to do the same in other international markets.