FDA Advisory Panel Gives Nod to Esketamine Nasal Spray, Paving Way for FDA Approval

An independent advisory panel to the Food and Drug Administration (FDA) on Tuesdayendorsed the esketamine nasal spray Spravato for the treatment of adults with treatment-resistant depression. The rapid-acting antidepressant was developed by the Janssen Pharmaceutical Companies of Johnson& Johnson. While the FDA is not required to follow the recommendation of the panel, the agency does take its advice into consideration.In a 14-2 vote with one abstention, the Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee concluded the benefits of esketamine outweigh the risks.The committees ’ vote on the safety and effectiveness of esketamine was based in part on the results of five phase 3 studies of esketamine in patients with treatment-resistant depression. As described inbackground materials made available on the FDA website ahead of the meeting, these studies included three short-term, double-blind, placebo-controlled studies; one randomized withdrawal maintenance-of-effect study; and one long-term, open-label safety study. To participate in these studies, patients were required to have failed at least two prior antidepressant trials at study entry. In each trial, patients were assigned to receive esketamine or placebo in addition to a newly initiated oral antidepressant.According to theFDA briefing document, the evidence in support of esketamine ’s effectiveness derives primarily from two positive phase 3 trials, which showed t...
Source: Psychiatr News - Category: Psychiatry Tags: esketamine FDA Janssen Johnson & NMDA Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee REMS Spravato treatment-resistant depression Source Type: research