Potent twist on party drug could offer key to treating depression
A VARIANT of the party drug ketamine has been licensed in the US for treatment-resistant depression.
The decision comes as the European Medicines Agency (EMA) considers a similar application, which could lead to British patients being given the powerful anaesthetic. The US Food and Drink Administration yesterday licensed the nasal spray for use by those who have already tried at least two medications for depression without success.
The licence means patients can only receive the treatment, called Spravato, under medical supervision.
The EMA is expected to take a decision on a similar application by drugs firm Janssen, part of Johnson & Johnson, later this year or next year. British regulators are likely to take its ruling into account before deciding whether to authorise use of the drug.
Clinical trials suggest it is up to 10 times more effective than current drugs in people suffering from treatment-resistant depression.
The drug comes in the form of esketamine, a mirror image of the ketamine molecule, which is far more potent. Scientists say it is the first new drug for 35 years for depression, with no major breakthroughs since the launch of treatments like Prozac in the Eighties.
Those drugs target the feel-good brain chemical serotonin and can take weeks or months to kick in.
The new drug works differently, targeting a chemical called glutamate that is thought to restore brain connections that help relieve depression.
British trials on more than 800 patients showed remission rates of 47 per cent, compared with 4 per cent for current antidepressant drugs.
Trials found the drug could relieve depressive symptoms within hours, helping those suffering from acute crises. Yesterday, the Food and Drink Administration warned that the drug has risks of serious side effects – including nausea, sedation and suicidal thoughts.
The drug label will contain a “boxed warning” to alert patients to the risk of “sedation, and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviours after administration of the drug”, the agency said.