US FDA approves esketamine nasal spray for treatment-resistant depressionAugust 8, 2020 0 By FM
Esketamine (Spravato) CIII nasal spray has recently received US FDA approval for use in conjunction with an oral antidepressant in adults for treatment-resistant depression (TRD), announced the Janssen Pharmaceutical Companies.
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 right dose and duration in the current depressive episode.
Esketamine 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 bloodstream.
Esketamine was studied in a phase 3 clinical trial programme with more than 1,700 adults with TRD. In a short-term study, those who took esketamine and an oral antidepressant experienced a 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 esketamine 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 esketamine when used along with an antidepressant taken orally included dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.