The Johnson and Johnson NMDA regulator spravato (esketamine) was recommended by the FDA board for approval

, owned by U.S. pharmaceutical giant Johnson and Johnson (JNJ), recently announced a meeting of the U.S. Food and Drug Administration's Advisory Committee on Psychopharmic Drugs (PDAC) and the Advisory Committee on Drug Safety and Risk Management (DSaRM) to combat the depression drug Spravato (eske) The new drug application (NDA) for the nasal spray CIII was reviewed and voted jointly (14 votes in favor, 2 against, 1 abstention), arguing that NDA data supported the risk of benefits for adult patients treated with Spravato nasal spray CIII for incurable depression.
Janssen Pharmaceuticals announced on September 4, 2018 that it had submitted an NDA application to the FDA for approval of Spravato's treatment for adult patients with severe depression (MDD). Although the FDA is not bound by the advisory board's recommendations, it will consider them. Spravato's Prescription Drug User Charge Act (PDUFA) targets March 4, 2019. If approved, Spravato would be the first MDD treatment with a new mechanism in the past 30 years.
Huseini K. Manji, global director of neuroscience therapy at Janssen Research and Development, said, "We are pleased with the advisory committee's vote and its recommendation to approve Spravato as a potential treatment for adults with resoicative depression." Our extensive research projects provide a positive benefit risk for Spravato nasal sprays for adult patients with refroutable depression. The
Advisory Committee's support for the approval of Spravato nasal sprays is based on safety and efficacy data from five Phase III clinical studies conducted in adult patients with refroutable depression, including 3 short-term studies, one maintenance effect study, and one long-term safety study. In addition, the Spravato research project provided support data for three Phase II studies and 19 Phase I studies conducted in patients with resoicative depression and healthy volunteers. Data from a short-term Phase III study and a long-term Phase III study showed that Spravato nasal sprays combined with a newly launched oral antidepressant led to statistically significant, clinically significant, rapid and sustained improvements in depressive symptoms in this refroutable group. All patients in the Group III study received Spravato or a placebo at the beginning of the treatment period, in addition to a newly initiated oral antidepressant.
long-term safety studies have shown that Spravato is generally tonable, with no new safety signals during the 52-week treatment compared to data from the short-term (4-week) study. The low rate of drug suspension due to Spravato-related adverse events usually occurs in the first week. Most adverse events that occur during treatment, including dissopathy symptoms, dizziness/dizziness, elevated blood pressure and sedation, occur shortly after being given medication, and are short-lived and resolved on the same day under the supervision of a health care professional. In addition to a comprehensive clinical research program, the company has developed a robust Risk Assessment and Mitigation Strategy (REMS).
Spravato: The first antidepressant in 30 years with a new mechanism of action
Spravato's active drug ingredient is esketamine, a non-competitive and subtype of non-selective activity-dependent N-methyl-D-tiandysteine (NMDA) patient antagonist, with a new and unique mechanism of action that works differently from other drugs currently on the market for depression.
is that the drug has a quick, long-lasting and powerful effect in the group of people with resoicable depression. The data showed that for most depressive patients on the market with antidepressants, when they switched to esketamine treatment, the patient's mood improved incredibly significantly in just a few days, and the effect lasted for a very long time. Most antidepressants on the market today often take weeks or even months to take effect.
, the FDA has previously granted esketamine a breakthrough drug for the treatment of resusable depression and treatment for severe depression associated with an imminent risk of suicide. If approved, the drug would be one of the first new FDA-approved treatments for severe depression in the past 30 years. Compared to standard oral therapeutic drugs, the in-nasal esketamine administration method provides the advantage of rapid effectiveness. (Bio Valley)