30 years first new mechanism antidepressant approved! Johnson & Johnson spravato will be used for the treatment of refractory depression

Yang Sen pharmaceuticals, a US pharmaceutical company under Johnson (JNJ), announced in March 5th that the US Food and Drug Administration (FDA) has approved Spravato (esketamine) CIII nasal spray combined with oral antidepressants for the treatment of adults with refractory depression (TRD) For patients who are currently suffering from severe depression, if their depressive episode does not respond adequately to at least two different antidepressants in sufficient dose and duration, it is considered as TRD It is estimated that about one third of adults with major depression in the United States are TRD This approval makes spravato the first antidepressant with a new mechanism of action in the past 30 years In the United States, the FDA has previously licensed spravato for TRD and breakthrough drugs for severe depression with an urgent risk of suicide Compared with the standard oral treatment drugs, spravato can provide the advantage of quick effect through intranasal administration It should be noted that the spravato drug label is accompanied by a black box warning that indicates the risk assessment and mitigation strategy (REMS) and the risk of suicidal thoughts and behaviors in paediatric patients and young adults 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 NMDA receptor is a subtype of ionotropic glutamate receptor, which plays a key role in synaptic plasticity and information exchange between neurons In depression, blocking NMDA receptors is believed to improve brain plasticity and enhance synaptic connections The efficacy and safety of esketamine (image source: Wikimedia) spravato were studied in a phase III clinical project involving more than 1700 adult patients with TRD In the short-term study, patients with spravato plus oral antidepressants showed significant improvement in depressive symptoms at week 4 compared with patients taking placebo and an oral antidepressant In the long-term study, the risk of relapse was reduced by 51% in patients who continued treatment with the combination of spravato compared to patients who maintained placebo and oral antidepressant regimens In the study, the most common side effects of the combination of spravato and oral antidepressants were dissociation, dizziness, nausea, sedation, dizziness, loss of touch and sensation, anxiety, lack of energy, elevated blood pressure, vomiting and drunkenness "Depression is a common, potentially debilitating disease that has profound emotional, functional, and economic implications for those who suffer and those they love," said Michael E thase, lead researcher at the spravato clinical trial site and professor of psychiatry at the University of Pennsylvania's Perelman School of medicine and director of mood and anxiety disorders treatment and research program For those who fail to benefit from standard treatment, depression has a big impact In the phase III clinical study, we observed that spravato therapy can bring rapid and continuous improvement to TRD patients " Mathai Mammen, global head of Janssen R & D, said: "spravato has the potential to change the treatment of depression, providing new hope for an estimated one-third of patients with major depression who do not respond to existing antidepressants This unique and innovative drug is the latest achievement of Janssen's continuous commitment to advancing solutions in the field of neuroscience to heal the mind and improve health outcomes " Once spravato has been identified as the appropriate treatment option, the patient will be treated at a certified treatment center under REMS Spravato will not prescribe directly to patients for use at home The drug will be taken by patients themselves under the direct observation of health care providers, and sedation, dissociation and blood pressure changes will be observed for at least 2 hours, and patients can leave until they are confirmed safe In addition, after getting a good sleep, the patient can not drive or operate the heavy machinery until the next day All patients will be registered in the spravato REMS registry to further describe the risk of serious adverse consequences of sedation, dissociation, abuse and misuse, and to support the safe use of the drug In addition, Janssen carepath will provide a comprehensive support program to help patients start spravato treatment and keep track 1 Janssen announcements U.S FDA approval of spravatotm (esketamine) CIII nasal spray for results with treatment resistant expression (TRD) who have cycled through multiple treatments without relief 2 FDA approval new nasal spray media for treatment resistant expression; available only at a certified doctor’s office or clinic