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New depression drug Spravato lands in the 'Big 5' Hospitals
by Eo, Yun-Ho Dec 16, 2021 05:52am
Janssen’s new drug for depression, ‘Spravato,’ can now be prescribed at general hospitals in Korea. According to industry sources, Spravato (esketamine) that is used in combination with an oral antidepressant, has passed the review of drug committees (DC) of 80 medical institutions in the nation including the 'Big-5' general hospitals - Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul St. Mary’s Hospital, and Severance Hospital - as well as the Kyung Hee University Medical Center, Kyungpook National University Hospital, Inje University Paik Hospital, Seoul National University Bundang Hospital, Chung-Ang University Hospital, Jeju National University Hospital, Inje University Haeundae Paik Hospital. Spravato, which was approved in June last year in Korea, was the first-ever prescription nasal spray with a new mechanism of action that was introduced in the field of treatment-resistant depression (TRD) and the first in 30 years introduced in the field of major depressive disorder. Spravato’s esketamine modulates the glutamate receptor called an N-methyl D-aspartate (NMDA) receptor in the brain and restores synaptic function and increases neurotrophic signaling to improve depression symptoms. Last year, the drug added an indication for the treatment of major depressive disorder with suicidal thoughts or actions. The approval of the depression with suicidal ideation indication was based on results of the global Phase III ASPIRE I and ASPIRE II study. In both ASPIRE I and ASPIRE II, Spravato met the primary endpoint as defined as the reduction in depressive symptoms from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) at 24 hours after the first dose when taken in conjunction with standard of care therapy (including oral antidepressants and hospitalization). Efficacy for the initial indication of treatment-resistant depression was demonstrated through a Phase 3 clinical trial consisting of short- and long-term trials that were conducted on 1,700 adult patients with treatment-resistant depression. In the short-term clinical trial on patients aged 18 to 65 years with treatment-resistant depression, the MADRS score of patients who were administered Spravato in combination with oral antidepressants was lowered by 19.8 points during the 4-week treatment period. Patients who were administered a placebo showed a 15.8 point reduction in the MADRS score, demonstrating a statistically significant improvement in symptoms of patients who used Spravato with an oral antidepressant. In the long-term trial, the probability of recurrent depressive symptoms was 51% percent lower in the Spravato +oral antidepressant-treated group that achieved stable remission than that of the placebo+oral antidepressant-treated group. Jong-woo Paik, Professor of Mental Health and Medicine at Kyunghee University, said, “Unlike other antidepressants that take several days for symptoms to improve after intake, Spravato showed immediate improvement in depressive symptoms. Such a characteristic is particularly effective in treating and managing patients in emergencies such as those who had attempted suicides.”