Johnson & Johnson scored a win for their new Spravato drug after an advisory panel voted 14-2 in favor of FDA approval as a treatment for certain types of depression – including treatment-resistant depression.
Used in a nasal spray form, esketamine (closely related to analgesic ketamine) is a fast-acting anti-depressant believed to work differently than more traditional forms of drug therapies. For those who suffer from depression, it means new hope may be on the horizon.
Dr. Husseini Mani, global head, neuroscience therapeutic area, Johnson & Johnson’s pharmaceutical division Janssen, stated that “one third of patients with major depressive disorder do not respond to existing therapies, and they need new treatment options.”
However, Janssen is not the only one that’s been exploring other potential therapeutic uses for ketamine. Last year, California-based VistaGen received fast-track approval from the FDA for a promising pill version called AV-101.
Called the Psychopharmacologic Drug Advisory Committee, they are responsible for evaluating the safety and effectiveness of pharmaceutical products and making recommendations to the FDA. Based on information from five Phase III studies with patients experiencing treatment resistant depression, they supported the Spravato application from Janssen.
“Together with the…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,” Manji said of the studies’ results.
In recent years, ketamine has been used as an off-label prescription option for those with depression. Patients are referred to expensive “ketamine clinics” where they are charged $650 to $1200 per treatment. It’s not unusual for patients to need up to eight doses to see improvement and most insurance plans won’t cover the costs since it’s not a recognized treatment.
While the FDA is not bound by the committee’s recommendations, it is unusual for the regulator to go against their decision and all signs point to a positive result for Spravato’s availability to the public. “We are pleased with the advisory committee’s vote and their recommendation to approve Spravato as a potential therapy for adults living with treatment-resistant depression,” Manji stated.
The Food and Drug Administration is expected to issue their decision regarding approval on March 4th.
