New medicine for depression! Axsome compound drug axs-05 (dextromethorphan / bupropion release agent) has entered the stage III clinical treatment of refractory depression!

January 24, 2020 / BIOON / -- axsome therapeutics is a clinical stage biopharmaceutical company focusing on the development of innovative therapies for central nervous system (CNS) diseases Recently, the company announced that the phase III stride-1 study to evaluate axs-05 (dextromethorphan / bupropion) in the treatment of refractory depression (TRD) has completed patient randomization Patients diagnosed with major depression (MDD) are defined as refractory depression (TRD) if they fail to treat two or more antidepressants MDD is a serious disease characterized by depression, loss of interest or pleasure in daily activities for at least two weeks, and impairment of social, vocational, educational or other important functions The National Institutes of Health (NIH) estimates that about 7.1% of American adults experience MDD every year Nearly two-thirds of the patients who were diagnosed and treated did not get enough response to the first-line treatment, and most of the patients who failed in the first-line treatment also failed in the second-line treatment Axs-05 is a new oral NMDA receptor antagonist with multimodal activity, which is currently under clinical development for the treatment of depression and other central nervous system (CNS) diseases Axs-05 is made up of the exclusive formula and dosage of dextromethorphan and bupropion, and adopts axsome's metabolic inhibition technology The dextromethorphan component of axs-05 is a noncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as glutamate receptor modulator, which is a new mechanism of action, which means that its effect is different from most depression drugs currently available The dextromethorphan component of axs-05 is also a sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, serotonin and noradrenaline transporter inhibitor Axs-05 is a norepinephrine and dopamine reuptake inhibitor and a nicotinic acetylcholine receptor antagonist Axs-05 has more than 30 U.S and international patents until 2034 In the United States, the FDA has awarded axs-05 breakthrough drug qualification (BTD) for the treatment of major depression (MDD) and fast track qualification (FTD) for the treatment of refractory depression (TRD) In December 2019, axsome announced the results of the phase III Gemini study of axs-05 in adults with severe MMD The data showed that the study reached the main end point: compared with placebo group, axs-05 treatment group showed substantial, rapid and statistically significant reduction of depression symptoms: the total score of the Montgomery Spielberg Depression Scale (MADRS) in the 6th week of treatment achieved a statistically significant reduction compared with the baseline (mean reduction compared with the baseline: 16.6 points vs 11.9 points, P = 0.002) All secondary endpoints also showed significant improvement In the treatment of depression, Johnson antidepressant drug Spravato (esketamine nasal spray) is the first new antidepressant drug that has been approved for more than 30 years In the United States and the European Union, spravato was approved in March and December 2019, respectively, to treat adult patients with refractory depression (TRD) in combination with oral antidepressants At present, spravato's application for expanded indications is being reviewed by us and European regulatory agencies: as an acute short-term treatment drug, it is used in combination with oral antidepressants for adult patients with moderate to severe depressive episodes and suicidal ideation of major depression (MDD) 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 MDD patients assessed as having an imminent risk of suicide constitute a mental emergency requiring immediate intervention Although currently available antidepressants are effective in the treatment of depression, they usually take weeks (4-6 weeks) to achieve full effect This delay has potential risks, especially since the risk of suicide is highest early in the treatment Compared with the standard oral treatment drugs, spravato can provide the advantage of quick effect through intranasal administration 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 Original source: axsome therapeutics completes patient randomization in the stride-1 phase 3 trial of axs-05 in treatment resistant expression