Janssen Pharmaceutical has secured recommendation from the US Food and Drug Administration (FDA) advisory committees for the approval of its esketamine nasal spray Spravato to treat adults with treatment-resistant depression.
The committees voted 14-2 in favour of the drug, saying that its benefits outweighed the risks.
Esketamine is chemically similar to often-abused anaesthetic ketamine.
It is an investigational, glutamate receptor modulator designed to potentially restore synaptic connections in brain cells of patients with major depressive disorder (MDD).
The company said that the mechanism of action of the drug is thought to be different than existing therapies for the mental disorder.
If the FDA approves Spravato, it will be the first major therapeutic advance for depression since the launch of Prozac in 1987, Bloomberg noted.
Janssen Research & Development Neuroscience Therapeutic Area global head Husseini Manji said: “We are pleased with the advisory committees’ vote and their recommendation to approve Spravato as a potential therapy for adults living with treatment-resistant depression.
“Our comprehensive research programme for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression.”
The committees’ decision is based on safety and efficacy data obtained from three short-term, one maintenance of effect, and one long-term safety Phase III studies.
Results from both the short-term and long-term studies revealed that the esketamine nasal spray in combination with a new oral antidepressant led to a statistically significant, clinically meaningful, rapid and sustained improvement of depressive symptoms.
Furthermore, the company provided supportive data from three Phase II and 19 Phase I trials conducted in patients with treatment-resistant depression and healthy volunteers.
In a separate development, Janssen obtained FDA approval for a split-dosing regimen of its Darzalex drug for the treatment of multiple myeloma.
The approval allows splitting the first infusion of the drug over two consecutive days.