J&J files esketamine nasal spray antidepressant in US
An esketamine-based nasal spray antidepressant for adults is under review in the US following a filing from Johnson & Johnson’s pharma unit.
Janssen has submitted a filing for esketamine to the US Food and Drug Administration (FDA) to help people who have treatment-resistant depression.
Around 30% of sufferers do not respond to current standard treatments, helping to make major depressive disorder the leading cause of disability worldwide.
The filing must prove that the drug is safe and will be effective for the intended recipients. If the FDA is happy with the application, there will be a six to 10 month period within which approval can be granted.
If approved, esketamine will be the first drug of its kind to be used to treat depression. The drug is a reformulation of ketamine, an anaesthetic, which has been illegally used as a party drug and implicated in cases of so-called ‘date rape’, as its effects are so powerful.
Janssen has engineered the fast-acting drug so that it can help restore connections between brain cells. Esketamine works in a different way to standard treatments for depression, by affecting glutamate receptor modulation. Glutamate is the most prominent neurotransmitter in the body and is present in more than 50% of nervous tissue.
Mathai Mammen, global head, Janssen Research & Development, said, “Of the nearly 300 million people who suffer from major depressive disorder worldwide, about one-third do not respond to currently available treatments. This represents a major unmet public health need.
“We are committed to working with the FDA to bring this new treatment option to US patients with treatment-resistant depression and to the medical community.”
Five phase 3 studies of esketamine nasal spray in patients with treatment-resistant depression revealed that the latter plus a newly initiated oral antidepressant, compared to a placebo plus the oral medicine, was associated with rapid reduction of depressive symptoms and delayed time to relapse of symptoms of depression.
If approved, esketamine would be self-administered by patients, under the guidance of doctors.
Janssen plans to submit a filing with the European Medicines Agency for esketamine later this year.
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