The first new mechanism antidepressant in 30 years! J & J NMDA receptor antagonist spravato nasal spray will be approved by EU by the end of this year!

October 22, 2019 / BIOON/ - Yang Sen pharmaceuticals, the US pharmaceutical giant Johnson (JNJ), recently announced that the European Medicines Administration (EMA) Commission on human medicines (CHMP) has issued positive reviews, recommending approval of the antidepressant Spravato (esketamine) nasal spray, combined with a selective 5- hydroxytryptamine reuptake inhibitor (SSRI) or 5- HT and norepinephrine reuptake inhibitor (SNRI) ）For the treatment of adult patients with refractory severe depression (TRD) Patients with depression are considered to have TRD if they do not respond to at least two different antidepressant treatments in their current episode of moderate to severe depression CHMP's comments will be reviewed by the European Commission (EC), which will take a decision in the fourth quarter If approved, spravato will become the first major depression (MDD) treatment drug with a new mechanism in Europe in 30 years Compared with the standard oral therapy drugs, the intranasal administration of esketamine will provide the advantages of rapid effect In the United States, spravato has been approved by FDA in March this year, becoming the first antidepressant drug with new mechanism in the U.S market 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 Earlier this month, Janssen submitted a new drug supplement application (SNDA) to the FDA, seeking approval for spravato, a new indication for adults 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 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 The amazing thing about esketamine is that it has a quick and long-lasting therapeutic effect in TRD patients Data shows that for most of the depression patients on the market who are difficult to treat with antidepressants, when they turn to esketamine for treatment, within just a few days, their mood has been improved significantly, and the effect lasts for a very long time At present, most antidepressants on the market often need to take weeks or even months to take effect Spravato (esketamine): the first new antidepressant Spravato nasal spray in Europe has been applied in Europe for marketing authorization applications (MAA) in the past 30 years, mainly based on the safety and efficacy data of 5 III phase clinical studies carried out in TRD adult patients, including 3 short-term studies, a randomized withdrawal and maintenance effect study, and a 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: Janssen receives positive CHMP opinion for spravato ® (esketamine) nasal spray for results with treatment resistant major expressive discorder