Esketamine Receives Support from 2 FDA Committees

Feb 13, 2019 | CenExel CBH, Depression, News

Esketamine, a drug developed by Johnson & Johnson for the treatment of depression has received support from two FDA committees. Final FDA approval is expected by March 2019.

The drug has been approved for use in treatment resistant depression.

From the article: The committees based their support on the safety and efficacy data from five Phase III studies in patients with treatment-resistant depression: three short-term studies; one maintenance of effect study; and one long-term safety study. In addition, the SPRAVATOTM research program provided supportive data from three Phase II studies and 19 Phase I studies in patients with treatment-resistant depression and healthy volunteers. Data from both a short-term Phase III study and a long-term Phase III study demonstrated that esketamine nasal spray plus a newly initiated oral antidepressant provided statistically significant, clinically meaningful, rapid, and sustained improvement of depressive symptoms in this difficult-to-treat population.4,5 All the patients who participated in the Phase III studies received esketamine or placebo in addition to a newly initiated oral antidepressant at the start of the treatment phase.

You can read more here: FDA Advisory Committee Recommends Intra-Nasal Esketemine for Treatment Resistant Depression

Here at CBHHealth, we have several current depression clinical trials which focus on esketamine and other similar compounds. If you have treatment resistant depression, consider applying for one of our depression research trials.