EU regulators review Janssen's esketamine nasal spray antidepressant
An application for Janssen’s investigative nasal ketamine-based antidepressant is under review in Europe.
Janssen, which is Johnson & Johnson’s pharma unit, submitted a filing to the European Medicines Agency for esketamine nasal spray, which is designed to help people with treatment-resistant depression (TRD).
The application covers adults who have not responded to at least two different treatments with antidepressants in their current moderate-to-severe depressive episode. Around 30% of people with major depression do not respond to current treatment.
If the European Commission approves the fast-acting drug, it will be groundbreaking, as it will be the first ketamine-based medicine to treat depression.
Ketamine is an anaesthetic, which has been notoriously and illegally used as a party drug and implicated in cases of so-called ‘date rape’, as its effects are so powerful.
The reformulated ketamine works by affecting glutamate receptor modulation. Glutamate is the most prominent neurotransmitter in the body and is present in more than 50% of nervous tissue. Esketamine helps to restore connections in the brain.
Five phase 3 studies of esketamine nasal spray in patients with TRD demonstrated 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.
The medicine was effective as early as day two and the long-term safety study showed that the nasal spray doses studied were generally tolerated, with no new safety signals reported during one year, when compared to the findings from the short-term studies of the spray.
The nasal spray formulation is currently in phase 3 clinical development and is not yet approved for any indications; its safety and efficacy profile is still being investigated.
If approved by the European Commission, the spray would provide the first new mode of action to treat TRD seen in the last 30 years. It would be self-administered by patients, under the guidance of a doctor.
Husseini Manji, global head, neuroscience therapeutic area, Janssen Research & Development, said: “The results from our Phase 3 studies reinforce the potential of esketamine nasal spray as a novel treatment to help patients who haven’t responded to available therapies.
“We look forward to bringing a new treatment option to people who need it most.”
The company submitted an application to the US Food and Drug Administration last month.