US health officials have allowed esketamine, a chemical similar to the party drug and anesthetic ketamine, to be used for treating depression. The new drug will be distributed by Johnson & Johnson as a nasal spray.
In a landmark decision on Tuesday, the Food and Drug Administration (FDA) approved the use of the chemical esketamine for treating people who suffer from depression and are resistant to other types of treatment.
At the same time, the FDA warned of potential "abuse and misuse" of the drug similar to ketamine. The anesthetic can cause mild psychedelic effects, a feeling of separating the mind from the body and is often abused as a party drug labeled "Special K."
The approval of esketamine marks the first time a new type of antidepressant would hit the US market since the approval of Prozac and Prozac-like drugs three decades ago. US pharmaceutical giant Johnson & Johnson (J&J) said its esketamine-based "Spravato" nasal spray was found to relieve depression symptoms within 24 hours in some patients.
"Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies," said Mathai Mammen, global head of J&J's Janssen Research & Development.
Unlike Prozac, which blocks the absorption of serotonin in the brain, Spravato aims to restore nerve connections in the brain areas related to mood, according to J&J.
However, the immediate impact of ketamine is estimated to last four to seven days and the benefit from long-term treatment it is not yet clear.
The FDA said there are "risks of serious adverse outcomes" when using Spravato, such as sedation and dissociation. The drug should only be used under medical supervision and patients would not be allowed to take it home.
However, Kim Witczak, a member of an FDA advisory panel that voted in favor of esketamine in February, warned that the FDA's restrictions "are not enforceable and the drug companies are responsible for managing and reporting to the FDA."
Wall Street analysts predict over $600 million (€531 million) in annual sales of Spravato by 2022.
dj/amp (AFP, AP, Reuters)