Treating Alzheimer's (AD) is exciting! The FDA has awarded AXS-05 (right metafen/amphetamine transfer agent) breakthrough drug qualification!

, June 27, 2020 /PRNewswire-BIOON/Axsome Therapeutics is a clinical-phased biopharmaceutical company focused on developing innovative treatments for central nervous system (CNS) diseasesRecently, the company announced that the U.SFood and Drug Administration (
FDA) has awarded AXS-05 (right metafen/amphetamine- conditioner) breakthrough drug qualification (BTD) for the treatment of Alzheimer's disease (AD) Currently, no drug has been approved for the treatment of ADnote that this is the second time that AXS-05 has been granted BTD by the FDAPreviously, theFDAhas awarded AXS-05 btD for the treatment of severedepression(MDD), as well as fast-track (FTD) for the treatment of incurabledepression(TRD) and ADBTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases and have initial clinical evidence that the drug can significantly improve the condition compared to existing therapeutic drugsThe BTD-acquired drug is developed with closer guidance, includingFDA senior officials, to ensure that patients are given new treatment options in the shortest possible time Alzheimer's disease (AD) is the most common type of dementia characterized by cognitive decline, behavioral and psychological symptoms including restlessness In 70% of AD patients, the increase in irritability was observed, associated with accelerated decline in cognitive ability, early placement in nursing homes, and increased mortality Clinical studies have shown that AXS-05 can significantly improve the aggressiveness of AD patients rapidly, substantially, and significantly compared to placebos AXS-05 is a new, oral, proprietary NMDA receptor antagonist with multi-modal activity and is currently in clinical development for the treatment of depression
and other central nervous system (CNS) diseases The AXS-05 consists of proprietary formulations and doses of dextromethorphan and bupropion, and uses Axsome's metabolic inhibition technology AXS-05 right mesamine component is a non-competitive N-methyl-D-Tinnine (NMDA) receptor antagonist, also known as glutamate receptor regulator, which is a new mechanism of action, meaning that it acts differently from most depression drugs currently available AXS-05's right mesafen component is also a sigma-1 receptor agonist, niacline acetylcholine receptor antagonist, serotonin and norepinephrine transporter inhibitors AXS-05's amphetamine strain, which improves the bioavailability of right mesafen, is a norepinephrine and dopamine reuptake inhibitor and an aphorine acetylcholine receptor antagonist The AXS-05 holds more than 40 U.S and international patents for protection until 2034 now, AXS-05 has been proven effective in Alzheimer's, depression, and smoking cessation trials In addition, AXS-05 showed rapid efficacy in both Alzheimer's and depression compared to both positive drugs and placebo control groups "This BTD is an important milestone in the development of aXS-05 treatment for AD," said Herriot Tabuteau, chief executive of Axsome The more severe, widespread and debilitating adisease adilating adl is present, there is currently no approved treatment This is also the second BTD obtained by AXS-05, highlighting the potential of AXS-05 to address the unmet medical needs of many difficult central nervous system diseases We look forward to working with FDA in the coming months to advance the development of AXS-05 treatment AD "
this BTD, based on data from the II/III ADVANCE-1 study This is a randomized, double-blind, controlled, multicenter, U.S trial designed to assess the efficacy and safety of AXS-05 treatment for AD In the study, 366 patients were randomly treated with AXS-05 (dose increased to 45 mg/105 mg, 2 times a day), amphetamine (dose increased to 105 mg, 2 times a day), placebo for 5 weeks The main therapeutic indicator is the Cohen-Mansfield Emotional Behavior Scale (CMAI), or C.J CMAI is a scale of 29 caregivers that assessthets the frequency of aggressive behavior in people with dementia, including excessive motor activity (such as pacing, verbal aggression (such as screaming and shouting), and physical attacks (such as scratching, pushing, and beating) at the end of April, Axsome announced that the ADVANCE-1 trial had reached its main destination The data showed that in week 5, the total CMAI scores of patients in the AXS-05 group were statistically significantly reduced: the AXS-05 group decreased by an average of 15.4 points from the baseline and the placebo group decreased by an average of 11.5 points (p.010) These results represent an average percentage reduction from the baseline level to 48 per cent in the AXS-05 group and a decrease in the average percentage of the placebo group to 38 per cent AXS-05 also outperformed amphetaminein in total CMAI scores, confirming the contribution of the right metaxafen component in the drug AXS-05 can quickly improve symptoms of extrusion The improvement in The AXS-05 to CMAI total score from week 2 was numerically superior to the placebo, and was statistically significant only one week after the full dose of AXS-05 was achieved in the third week (p-0.007) the proportion of patients in the AXS-05 group who received clinical responses to CMAI (73% vs 57%, p-0.005) increased significantly in terms of CMAI compared to the placebo group, and the clinical response was defined as a 30% or higher increase in the baseline level These results are consistent with the overall assessment changes in clinicians using improved Alzheimer's collaborative studies- clinical change overall impression scale (mADCS-CGIC) measurements Compared to placebos, AXS-05 showed a statistically significant improvement (p-0.036) the test, AXS-05 was well tolerated The most common adverse reaction
s in the AXS-05 group were drowsiness (8.2 percent in AXS-05, 4.1 percent in the afensaclysone group and 3.2 percent in the placebo group), dizziness (6.3 percent, 10.2 percent, 3.2 percent) and diarrhea (4.4 percent, 6.1 percent, 4.4 percent, respectively) In the AXS-05, amphetamine and placebo groups, the rates of discontinuation due to adverse events were 1.3%, 2.0% and 1.3%, respectively Of the patients treated with AXS-05, 3.1% had severe adverse events, compared with 8.2% of patients treated with amphetamine and 5.7% for placebo No serious adverse events associated with the drug were detected in any treatment group There were 1 death in the placebo group, 1 death in the amphetamine group and 1 death in the AXS-05 group Small mental health check-up (MMSE) is a widely used general cognitive function measurement method, and there is no evidence of cognitive decline in patients treated with AXS-05 AXS-05 treatment is not related to sedation (BioValleyBioon.com) original source: Axsome Therapeutics The Serapy Therapy For AXS-05 for The Treatment of The Treatment's Disease .