Ketamine-like drug for depression gets UK licence

March 16th, 2024
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A radical ketamine-like drug has been licensed for use in the UK for severe depression, a decision that offers hope to the millions of patients for whom conventional treatments have failed.

Esketamine, taken as a nasal spray, is one of the first rapid-acting drugs for depression and the first in decades that is thought to work in a fundamentally different way in the brain. However, psychiatrists are divided on the benefits, with some hailing esketamine as a game-changer and others raising fears about the potential for addiction and abuse.

Prof Rupert McShane, a consultant psychiatrist and associate professor at Oxford University, said: “It’s undoubtedly an advance and a well-worked-out drug. It’s a drug, not a miracle. It doesn’t work for everyone, but it provides an opportunity.”

Unlike conventional antidepressants, which take weeks or months to take effect, esketamine has been shown, in some patients, to have enduring effects within hours.

The European Commission announced its decision on Thursday to approve the drug, which Janssen sells in the US under the brand name Spravato.

Before the drug can be marketed in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) must decide whether it will impose any additional safety requirements, such as patients being monitored for longer periods or the introduction of a registry.

There is no scheduled date for a decision, although this typically happens within months. The National Institute for Health and Care Excellence is also expected to rule in the first half of next year on whether esketamine will be available on the NHS.

European approval was based on a series of trials, including a long-term study showing that patients who had previously not responded to conventional drugs and who were given esketamine had a 51% lower risk of relapse than a similar group given oral antidepressants and a placebo nasal spray.

Prof Allan Young, the director of the Centre for Affective Disorders at King’s College London, said having another option could make a substantial difference to some of the roughly 2.7 million people in the UK who have chronic depression and have not responded to conventional drugs.

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