The US Food and Drug Administration (FDA) approved Spravato (esketamine), a nasal spray created by Janssen, a subsidiary of Johnson & Johnson, for treatment-resistant depression in conjunction with an oral antidepressant.
This approval comes shortly after the US FDA Psychopharmacologic Drug Advisory Committee recommended Spravato for approval based on its benefit-risk profile.
However, Spravato comes with a boxed warning regarding a Risk Evaluation and Mitigation Strategy (REMS) regarding the risk of suicidal thoughts and behaviors in young adult patients.
Spravato works on the N-methyl-D-aspartate (NDMA) receptor, an ionotropic glutamate receptor in the brain. It is absorbed through the lining of the nasal passages and into the bloodstream.
The treatment is approved only for use at a certified treatment center, and will not be dispensed directly to patients for home use. The patient will administer Spravato intranasally but only under the supervision of a healthcare provider, who will observe the patient for at least two hours.
Treatment-resistant depression is classified as major depressive disorder that has not responded to at least two different antidepressants at adequate doses during a depressive episode.
In a long-term study of the intranasal spray, majority of patients treated with Spravato were in stable remission. After continuing Spravato as a treatment and were shown to be 51% less likely to relapse compared patients given a placebo and oral antidepressant.
Diverting demand to street drugs
Esketamine, an antimere of the illicit drug ketamine, is the active ingredient in Spravato. Carla Canuso, psychiatrist and researcher at Janssen, previously told us, that esketamine has a greater affinity for the NDMA receptor than ketamine and, as a result, can be administered in lower volumes.
Addiction expert and MD at the Center for Network Therapy, Indra Cidambi, issued a statement expressing concern of the possible use of the ketamine derivative product.
“Ketamine is currently used as an anesthetic, but is also an abusable addictive street drug,” she said. Cidambi’s caution stemmed from the possible use of illicit ketamine by patients to replace the esketamine therapy delivered in treatment centers.
She stated, “If the cost to the patient is high and access to ketamine treatment difficult, it could divert demand to inexpensive street ketamine for immediate symptom relief and cause an explosion in addiction to ketamine.”
Cidambi explained in the statement that one in five individuals addicted to drugs are using illegal drugs to self-medicate unmet mental health care needs, most commonly using opiates.