The U.S. Food and Drug Administration (FDA) gave the green light to Janssen’s Spravato, an esketamine-based treatment for major depressive disorder. Approval came one month after an FDA advisory panel overwhelmingly supported approval of the nasal spray treatment.
The approval marks the first new approach for treating refractory major depressive disorder in nearly 50 years. Spravato is meant to be taken in conjunction with another anti-depression medication, such as Zoloft or another product.
Janssen’s esketamine nasal spray is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, which is also known as a glutamate receptor modulator. Janssen believes the treatment works by restoring synaptic connections in brain cells in individuals with major depressive disorder.
The approval of Spravato does not come without some concern, particularly over questions of the potential for abuse. Esketamine is related to the well-known party drug ketamine, also known by the street name Special K, which appears to induce a dreamlike sensation in some users. In addition to the potential for the dreamlike sensation, there were also some concerns that the treatment could increase blood pressure in some patients. While the FDA staff said ketamine abuse is “relatively uncommon in the general population,” Spravato does come with a black box warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors in pediatric patients and young adults.