Janssen

The U.S. FDA are set to debate the viability of Johnson & Johnson’s esketamine spray for major depression – a medication related to ‘party drug’ ketamine.

Votes from the FDA’s advisory committee however are not binding but rather serve as a general indication as to whether a drug will be approved according to the regulator’s recommendations.

Esketamine is a glutamate receptor modulator developed by Janssen, J&J’s pharmaceutical unit, which restores synaptic connections in brain cells in individuals with major depressive disorder.

Esketamine has also shown that it can induce a dreamlike sensation in some users, which has the regulator concerned that patients might abuse the drug.

In one of the trials being discussed about 69% of the study group responded to the drug after 4 weeks, compared to 52% in the intranasal placebo group.

Aside from concerns of misuse, the FDA already designated esketamine as “breakthrough therapy”, allowing for a faster review and development of the drug which offers a significant improvement over current available treatments.

Late last year, Husseini K. Manji, Janssen Research & Development’s Global Head, Neuroscience Therapeutic Area, said: “Together with the recently announced results from four other Phase III studies, these data provide continued support for a positive benefit-risk assessment for esketamine nasal spray as a potentially novel treatment approach for patients living with treatment-resistant depression. One-third of patients with major depressive disorder do not respond to existing therapies, and they need new treatment options.”

The FDA staff also did not forget to note there were six deaths in patients taking esketamine in the trial, three of which were by suicide. Since those patients already had treatment-resistant severe depression, it is unlikely to be a side effect of the drug itself.

Janssen stated that they had a target date of March 4th, with extra data on the suicidal patients expected later this year.

UPDATE: FDA Advisory Committee votes 14-2 in favour of the intranasal drug used alongside orally administered antidepressants in major depressive disorder.