Janssen Pharmaceutical announced that it has launched Spravato esketamine nasal spray in Australia for the treatment of treatment-resistant depression following approval by the TGA. The company also said that will file a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS).
Spravato is now approved in Australia for use with an oral antidepressant in adult patients who have failed to respond adequately to other antidepressants, and the nasal spray will be administered under medical supervision at more than 20 centers in Australia. Spravato has been approved in the US since March 2019 and in Europe since December 2019. Since then, expanded indications have been approved in both the US and Europe. Janssen launched the nasal spray in Canada in July 2020.
Janssen Australia and New Zealand Managing Director Biljana Naumovic said, “Janssen has a strong heritage in helping to reduce the burden, disability and devastation caused by mental illness and is committed to transforming individual lives. With the listing of Spravato, we are proud to have introduced the first new class of treatment for treatment resistant depression in over a decade. We recognize the need for a holistic approach to treatment resistant depression and know medicines are only part of the solution. We are committed to continuing our work, in partnership with Australia’s mental health community, to redefine the course of MDD and transform the mental health space for good.”
Read the Janssen press release.