Healing Alzheimer's! FDA grants AXS-05 breakthrough drug eligibility!

It is worth mentioning that this is the second time that the AXS-05 has been awarded BTD by the FDA.
, the FDA has granted AXS-05 BTD for the treatment of severe depression (MDD), as well as fast-track eligibility (FTD) for the treatment of refracingable depression (TRD) and AD.
BTD 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 to provide preliminary clinical evidence that the drug can substantially improve the condition compared to existing treatments.
access to BTD drugs and closer guidance at the time of development, including from senior FDA officials, to ensure that new treatment options are available to patients 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.
can be observed in 70 percent of AD patients, which is associated with accelerated cognitive decline, early placement in nursing homes, and increased mortality.
clinical studies have shown that AXS-05 can rapidly, substantially, and significantly improve the progression of AD patients compared to placebos.
AXS-05 is a new, oral, proprietary NMDA subject antagonist with multi-mode activity and is currently being clinically developed to treat depression and other central nervous system (CNS) diseases.
AXS-05 consists of proprietary formulations and dosages of dextromethorphan and bupropion, and uses Axsome's metabolic suppression technology.
AXS-05's right methafin group is a non-competitive N-methyl-D-tiantonine (NMDA) regulator, also known as a glutamate-intransigent, which is a new mechanism of action that means it functions differently from most depression drugs currently available.
the right methafin part of AXS-05 is also a sigma-1 subjector astigtor, niacin acetylcholine ligand antagonist, serotonin, and dethyrene transporter inhibitor.
AXS-05's amphetamine component improves the bio-utilization of right methafin, a dethyriphrine and dopamine reuptake inhibitor and a niacin acetylcholine inhibitor antagonist.
AXS-05 holds more than 40 U.S. and international patents until 2034.
, AXS-05 has been shown to be effective in Alzheimer's, depression, and smoking cessation trials.
, AXS-05 showed rapid results in Both the Alzheimer's and depression control groups compared to both positive drugs and placebo control groups.
BTD is an important milestone in the development of AXS-05 therapeutic AD, " said Dr. Herriot Tabuteau, Chief Executive Officer of Axsome.
AD is a serious, widespread and debilitating disease, and there are currently no approved treatment options.
is also the second BTD obtained by AXS-05, highlighting the potential of AXS-05 to address unseeded medical needs in many difficult-to-treat central nervous system diseases.
look forward to working with the FDA in the coming months to advance the development of AXS-05 therapeutic AD.
" BTD, based on data from the PHASE II/III ADVANCE-1 study.
this is a randomized, double-blind, controlled, multi-center, U.S. trial designed to evaluate the efficacy and safety of AXS-05 in treating AD aggressiveness.
in this study, 366 patients were randomly treated with AXS-05 (dose increased to 45 mg/105 mg twice daily), acetone (dose increased to 105 mg, 2 times daily), and placebo for 5 weeks of continuous treatment.
the main indicator of efficacy is the Cohen-Mansfield Emotional Behavior Scale (CMAI), or Koch Scale for short.
CMAI is a scale of 29 caregivers assessing the frequency of behavior associated with aggressiveness in people with dementia, including excessive physical activity (such as pacing), verbal attacks (such as screaming and shouting), and physical attacks (such as grabbing, pushing, and hitting).
end of April, Axsome announced that the ADVANCE-1 trial had reached its main end point.
data showed that in week 5, the total CMAI score of patients in the AXS-05 group was statistically significantly lower than in the placebo group: the AXS-05 group decreased by an average of 15.4 points from the baseline and the placebo group by an average of 11.5 points (p-0.010).
results represent a decrease of 48 per cent for the AXS-05 group from the baseline level and 38 per cent for the placebo group.
AXS-05 also outperformed acetone (p<0.001) in cmAI overall, confirming the contribution of the right methadone component in the drug.
AXS-05 can quickly improve the symptoms of aggressiveness.
improvement in the total CMAI score of AXS-05 from week 2 was numerically superior to that of placebo, achieving statistically significant statistical significantness only one week after the full dose of AXS-05 was used, i.e. week 3 .007.
compared to the placebo group, the proportion of patients in the AXS-05 group who received clinical responses to CMAI (73% vs. 57%, p-0.005) increased statistically significantly, defined as a 30% or higher increase in baseline levels.
these results are consistent with overall assessment changes measured by clinicians using the improved Alzheimer's Collaborative Study-Clinical Change Overall Impression Scale (mADCS-CGIC).
AXS-05 showed a statistically significant improvement over placebo (p.036).
the test, the AXS-05 was well resistant.
the most common adverse reactions in the AXS-05 group were drowsiness (8.2 per cent in the AXS-05 group, 4.1 per cent in the admoetone group and 3.2 per cent in the placebo group), dizziness (6.3 per cent, 10.2 per cent, 3.2 per cent) and diarrhoea (4.4 per cent, 6.1 per cent and 4.4 per cent, respectively).
in the AXS-05, acetone and placebo groups, the rates of drug suspension due to adverse events were 1.3%, 2.0% and 1.3%, respectively.
3.1 percent of patients treated with AXS-05 had severe adverse events, while 8.2 percent of patients treated with acetone and 5.7 percent were treated with a placebo, respectively.
no serious adverse events associated with the study drug were found in any of the treatment groups.
deaths in the placebo group, one death in the acetone group and none in the AXS-05 group.
small mental state examination (MMSE) is a widely used general cognitive function measurement method, there is no evidence of cognitive decline in patients treated with AXS-05.
AXS-05 treatment had nothing to do with sedation.
original origin: Axsome Therapeutics Receives FDA ProgramTherapy Designation for AXS-05 for The Treatment of Alzheimer's Disease Agitation Original title: Treatment of Alzheimer's (AD) FDA grants AXS-05 (right methafin/aphetamine dissociative) breakthrough drug eligibility!