Saturday, March 24, 2018

Esketamine for Depression

This post will focus on Johnson & Johnson's NMDA intranasal Esketamine (form of Ketamine) for treatment resistant depression or (TRD), with rapid onset of effect. Esketamine has received breakthrough therapy designation (BTD) from the FDA in 2013 for treatment-resistant depression, and again in 2016 for major depressive disorder with imminent risk of suicide.  JNJ through Janssen has several Esketamine phase 3 clinical trials for TRD patients currently running. Results from a phase 2 clinical study for patients 20-64 years of age with treatment resistant depression, (lack of treatment with at least two different oral anti-depressants) released results.  The results by Janssen showed a statistically significant effect, with ascending dose-response relationship, and response was observed as quickly as two hours post dose.  The side effect profile is better explained here JAMA Psychiatry in etable 4 supplemental 1. A rundown of the side effect profile from that supplemental is below. 
                                                                56mg                     84mg
Dizziness                                                40%                         47%
Headache                                               15%                          18%
Dissociation                                           35%                         24%
Dysgeusia                                               15%                          29%
Nausea                                                    20%                         24%
Dissociative  Disorder                           5%                          24%               
Oral Hypoesthesia                               20%                          12%     

We'll have to see how the FDA addresses the side effect profile of the intranasal drug. Thank you for reading.