Health Canada has issued a Notice of Compliance for Janssen Pharmaceutical’s Spravato esketamine nasal spray for the treatment of major depressive disorder, and the product is now available to Canadian patients, the company said. Spravato is meant to be used under direct supervision of a healthcare professional, and in combination with an oral antidepressant, when previous treatment with at least two different antidepressants has failed to achieve acceptable results.
Spravato has been approved in the US since March 2019 and in Europe since December 2019. Since then, Janssen has submitted an sNDA to the FDA and a Type II variation application to the EMA seeking to expand the indication to add the treatment of major depressive disorder with in patients who have active suicidal ideation with intent.
Mood Disorders Society of Canada National Executive Director Dave Gallson commented, “Mood Disorders Society of Canada is pleased that a new treatment option is available for adults with major depressive disorder who have failed multiple previous treatments. With 227 unique combinations of symptoms for someone with depression, new options that work in novel ways are essential.”
Read the Janssen Pharmaceutical press release.
