FDA approves Spravato for resistant depression

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the FDA has approved Spravato (esketamine) CIII nasal spray for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD). People who are currently struggling with major depressive disorder (MDD) are considered to have TRD if they have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode. It is estimated that approximately one-third of U.S. adults with MDD have TRD.

Spravato was studied in a robust Phase III clinical trial program with more than 1,700 adults with TRD. In a short-term study, those who took Spravato and an oral antidepressant experienced superior improvement in depression symptoms at four weeks, compared to those who received a placebo and an oral antidepressant. In a long-term study, patients in stable remission taking Spravato who continued treatment with the medicine were 51 percent less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant.

In the clinical trials, the most common side effects of Spravato when used along with an antidepressant taken by mouth included: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.

Comment: Spravato uses the first new mechanism of action in decades to treat MDD. Spravato works on the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor in the brain. The medicine is administered as a nasal spray that is absorbed by the lining of the nasal passages and into the blood stream.