Mental Health News 2019

The FDA’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee have voted in favor of approving esketamine nasal spray (brand name Spravato) for approval to treat major depressive disorder that not responded to other treatments. The exact wording of the indication will be announced if the drug is approved. What also remains to be seen is what special precautions or Risk Evaluation and Mitigation Strategy (REMS) the FDA will require. The FDA’s decision is expected on March 4, 2019, but the FDA usually follows the advice of its advisory committees. For details of the announcement and for the full document that was presented to the committees, see the links below:

https://www.jnj.com/fda-advisory-committee-recommends-approval-of-spravatotm-esketamine-nasal-spray-ciii-for-adults-with-treatment-resistant-depression