Johnson & Johnson's Spravato garners FDA approval for treatment-resistant depression

The FDA announced the approval of Johnson & Johnson's Spravato (esketamine), in conjunction with an oral antidepressant, for adults with treatment-resistant depression, with the nasal spray only available under a Risk Evaluation and Mitigation Strategy (REMS). Tiffany Farchione, acting director of the Division of Psychiatry Products in the agency's Center for Drug Evaluation and Research, said "because of safety concerns, the drug…must be administered in a certified medical office where the health care provider can monitor the patient."

The FDA added that Spravato labelling contains a warning that cautions that patients are at risk for sedation and difficulty with attention, judgment and thinking, abuse and misuse, and suicidal thoughts and behaviours after administration of the drug. The agency noted that because of the risk of sedation and dissociation, patients must be monitored by a health care provider for at least two hours after receiving their Spravato dose.

According to the FDA, the patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor's office or clinic, and the spray cannot be taken home. Farchione remarked "controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA's drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment."

Last month, an FDA advisory panel voted 14-2, with one abstention, that the benefits of Spravato outweigh its risks, while the committee voted by the same margin in favour of the effectiveness of the nasal spray and 15-2 in support of its safety. The agency noted that this is the first approval of esketamine, the s-enantiomer of ketamine, which works on the NMDA receptor, an ionotropic glutamate receptor in the brain.

The FDA noted that approval was supported by findings from three short-term studies and one longer-term trial. Results showed that in one of the short-term studies, Spravato demonstrated significant effect compared to placebo on the severity of depression, and some effect was seen within two days. However, the two other short-term trials failed to meet the pre-specified statistical tests for demonstrating effectiveness. Meanwhile, the agency said that in the longer-term maintenance trial, patients in stable remission or with stable response who continued treatment with Spravato plus an oral antidepressant experienced a significantly longer time to relapse of depressive symptoms than patients on placebo plus an oral antidepressant.

"Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies," remarked Mathai Mammen, global head of Johnson & Johnson's Janssen Research & Development division.

According to Janssen, the wholesale cost for a course of treatment of Spravato will be between $2360 and $3540, with the drug administered twice a week for four weeks, with further doses as needed. A marketing application for the drug, which analysts predict will generates sales of more than $600 million by 2022, is also under review in Europe with a decision expected later this year.

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