FDA advisory committee recommends approval of Spravato for depression.-Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted (14 yes, 2 no, 1 abstain) that data support the favorable benefit-risk profile of Spravato (esketamine) nasal spray CIII for adults living with treatment-resistant depression. Spravato is an investigational prescription treatment that is thought to work differently than currently approved therapies for major depressive disorder (MDD). Janssen announced on September 4, 2018 that it submitted a New Drug Application to the FDA for the approval of Spravato. If approved, Spravato would provide the first new mechanism of action in 30 years to treat this debilitating mental illness.

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 Spravato 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.

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. The long-term safety study showed that esketamine was generally tolerable, with no new safety signals with dosing up to 52 weeks compared to data from short-term (4-week) studies.