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Janssen’s Spravato (esketamine) gains approval with restricted distribution guidelines.
In approving Janssen Pharmaceutical’s Spravato (esketamine), a new drug for patients with treatment-resistant depression, on March 5, 2019, FDA warned of the risk of serious adverse outcomes and the potential for abuse, stipulating that the treatment be made available through a restricted distribution system.
The drug uses a new mechanism of action, working on the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor in the brain, according to a Janssen statement.
The medicine is administered as a nasal spray and is absorbed by the lining of the nasal passages and into the blood stream; the treatment is taken with an oral antidepressant. The drug must be administered in a certified medical office, cannot be removed from the medical facility, and the patient must be monitored for side effects.
The drug is prescribed for patients with major depressive disorder who did not respond to at least two antidepressant treatments.
Esketamine is the s-enantiomer of ketamine. FDA approved ketamine in 1970 as an anesthesia medicine; however, the drug has been misused as a “club drug.”
Spravato was approved with Fast Track and Breakthrough Therapy designations.
Sources: FDA and Janssen Pharmaceutical