The first new mechanism antidepressant in 30 years! Johnson NMDA receptor antagonist Spravato nasal spray is approved by the European Union to treat patients with refractory major depressive disorder.

December 20, 2019 / Biovalley BIOON/ -- Yang Sen pharmaceuticals, the US pharmaceutical giant Johnson (JNJ), recently announced that the European Commission (EC) has approved the antidepressant Spravato (esketamine) nasal spray, combined with a selective serotonin reuptake inhibitor (SSRI) or 5- serotonin and norepinephrine reuptake inhibitor (SNRI) for refractory severe depression (TRD) treatment of adult patients Patients with depression are considered to have TRD if they do not respond to at least two different antidepressants in their current moderate to severe depressive episode, according to approval This EC approval is valid in 28 EU Member States and European Economic Area (EEA) countries (Norway, Iceland, Liechtenstein) It is worth mentioning that with this approval, spravato has become the first antidepressant drug with new mechanism approved in Europe in 30 years The standard oral treatment usually takes 4 to 6 weeks to produce different effects Spravato is conveniently administered through nasal spray and can be quickly activated Globally, major depression (MDD) is the leading cause of disability, affecting nearly 40 million people of different ages in Europe Patients with depression (including MDD) continue to suffer from severe disease, which has a significant negative impact on physical function and all aspects of life Although the antidepressants currently available are effective in many patients, the onset time is 4 to 6 weeks, and about one third of patients have no response to the currently available treatment "EC approved Spravato nasal spray provides a new way to manage refractory severe depression through a new mechanism of action," said Dr Husseini K.Manji, head of the neuroscience therapy area at Yang Sen research and development company We are proud to introduce this new innovative treatment that will help address a major unmet medical need in the area of depression " In terms of U.S regulation, spravato has been approved by FDA in March this year, becoming the first antidepressant drug with new mechanism in the region in the past 30 years The drug is applicable to: combined with oral antidepressants, for the treatment of adult patients with refractory depression (TRD) Previously, FDA has awarded spravato a breakthrough drug qualification to treat TRD patients and MDD patients with imminent suicide risk In early October, Janssen also submitted a new drug supplement application (SNDA) to the FDA, seeking approval for spravato, a new indication for adult patients with severe depression (MDD) with strong suicidal ideation, to rapidly reduce depressive symptoms If approved, spravato will be the first drug to be used in a population of patients with serious illness who are usually excluded from antidepressant treatment studies Spravato (esketamine): the first antidepressant with new mechanism in 30 years The active drug component of spravato is esketamine, which is a non competitive and subtype non selective activity-dependent N-methyl-D-aspartate (NMDA) receptor antagonist It has a new and unique mechanism of action Its principle of action is different from other drugs on the market for the treatment of depression What's special about esketamine is that it has a quick and long-lasting therapeutic effect on TRD patients Data shows that when most of the depression patients on the market who are difficult to treat with antidepressants turn to esketamine treatment, within just a few days, the mood of the patients has improved significantly, while the effect lasts for a long time At present, most antidepressants on the market often need to take weeks or even months to take effect This EC approval is mainly based on the safety and efficacy data of five phase III clinical studies conducted in adult patients with TRD, including three short-term studies, one randomized withdrawal and maintenance effect study, and one long-term safety study Data from these studies, including more than 1600 patients treated with spravato, showed that the combination of spravato and a new oral antidepressant improved depressive symptoms on the second day of treatment compared to a newly initiated oral antidepressant and placebo nasal spray as an active standard of care (SOC) control Short term (1 month) study data showed that about 70% of patients treated with spravato responded to the drug and had a symptom reduction of ≥ 50% In addition, about half of the treated patients get relief, with good or no depression symptoms, which is the ultimate treatment goal of depression This high level of efficacy was maintained in most patients, and in the maintenance effect study, it was observed that compared with oral antidepressants alone, continuous use of spravato and oral antidepressants could reduce the recurrence risk of patients with stable remission by 51%, and the recurrence risk of patients with stable response by 70% The safety of Spravato nasal spray was also evaluated in the 5 key III phase studies and a II phase study, providing insights into the safety of Spravato combined with a long-term oral antidepressant treatment The data showed that over a 52 week treatment period, the risk / benefit was good, the efficacy continued, and there were no new safety issues The most common adverse reactions were dissociation, dizziness, nausea, sedation, headache, dizziness, hypoesthesia, high blood pressure, anxiety and vomiting These side effects are generally mild to moderate, transient and occur on the day of administration Original source: spravato (esketamine) nasal spray approved in Europe for results with treatment resistant major expressive discorder