Healthcare company Janssen Pharmaceutical Companies of Johnson & Johnson said on Tuesday that the US Food and Drug Administration (FDA) has recommended the SPRAVATO (esketamine) nasal spray CIII for adults living with treatment-resistant depression.

The company added that the US FDA Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted (14 yes, 2 no, 1 abstain) in favour of the data supporting the favourable benefit-risk profile of SPRAVATO (esketamine) nasal spray CIII for adults living with treatment-resistant depression.

According to the company, esketamine, an investigational prescription treatment, is a glutamate receptor modulator, thought to help restore synaptic connections in brain cells in people with major depressive disorder. It is believed to have a novel mechanism of action, meaning it is thought to work differently than currently available therapies for major depressive disorder.

If approved, SPRAVATO would provide the first new mechanism of action in 30 years to treat this debilitating mental illness, stated the company.

In conjunction, the US FDA's committees based their support on the safety and efficacy data from the company's five Phase 3 studies in patients with treatment-resistant depression: three short-term studies, one maintenance of effect study and one long-term safety study. The long-term safety study showed that esketamine was generally tolerable, with no new safety signals with dosing up to 52 weeks compared to data from short-term studies.

Individuals with depression, including major depressive disorder, experience continuous suffering from a serious, biologically based disease which has a significant negative impact on all aspects of life, including quality of life and function.