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    Home > Medical News > Latest Medical News > New medicine for incurable depression! AXS-05 significantly improves depressive symptoms and impaired function

    New medicine for incurable depression! AXS-05 significantly improves depressive symptoms and impaired function

    • Last Update: 2021-01-03
    • Source: Internet
    • Author: User
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    Patients diagnosed with severe depression (MDD) are defined as incurable depression (TRD) if two or more antidepressants fail.
    AXS-05 is a new type of oral N-methyl-D-tiandongine (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 methafenomephin is a non-competitive NMDA-subject antagonist, also known as glutamate-lipped regulator, 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 amphetamine component improves the bio-utilization of right methafin, a dethyroid and dopamine reuptake inhibitor and a niacin acetylcholine inhibitor antagonist.
    AXS-05 holds more than 30 U.S. and international patents and will be protected until 2034.
    U.S., the FDA has granted AXS-05 breakthrough drug eligibility (BTD) for the treatment of severe depression (MDD) and fast-track eligibility (FTD) for the treatment of refracurable depression (TRD).
    December, Axsome published the results of the Phase III GEMINI study of AXS-05 for adult patients with severe MMD.
    data show that the study reached its main endpoint: the AXS-05 treatment group showed a substantial, rapid, and statistically significant reduction in depressive symptoms compared to the placebo group: the overall score of the Montgomery-Sberg Depression Scale (MADRS) in week 6 achieved a statistically significant reduction relative to the baseline (average reduction relative baseline: 16.6 vs. 11.9 points, p.002).
    also shown significant improvement in all secondary endpoints.
    COMET-TRD trial evaluated 70 patients who received two or more antidepressants during their current depressive episodes but still had persistent depressive symptoms.
    study, patients received AXS-05 (45 mg right methadone-105 mg aphedone release tablets) twice a day for 12 months.
    results showed that the AXS-05 treatment showed rapid, significant and lasting improvement in depressive symptoms using the Montgomery-Asperger's Depression Assessment Scale (MADRS).
    patients treated with AXS-05, MADRS total score decreased by an average of 10.4 points in week 1, 14.7 points in week 2, and 20.6 points in week 6 (primary time point).
    after receiving AXS-05 treatment, 21.4% of patients in week 1, 44.1% in week 2, and 67.2% in week 6 achieved MADRS clinical response (defined as a decrease of ≥50%) in total score from baseline.
    after receiving AXS-05 treatment, 14.3 percent of patients in week 1, 19.1 percent in week 2, and 43.8 percent in week 6 achieved depression relief (defined as MADRS≤10).
    The improvement in depressive symptoms continued to be maintained or improved during long-term use of AXS-05: after 6 months and 12 months of treatment, the average maddRS score decreased by 22.9 and 26.3 points from the baseline, with 71.7% and 90.9% of patients achieving MADRS clinical response and 62.3% and 72.7% of patients achieving depression relief, respectively.
    the Sheehan Disability Scale (SDS), the patient's functional damage improved rapidly, significantly and permanently after treatment with AXS-05.
    SDS is a patient scale designed to assess function in work, social and family life and is one of the most commonly used functional damage scales in clinical trials of depression.
    after receiving AXS-05 treatment, 37.1% of patients in week 1, 52.9% in week 2, and 64.1% in week 6 achieved SDS clinical response (defined as total score ≤12).
    this functional improvement continued to be maintained or improved during long-term use of AXS-05 treatment: 69.8% and 91.7% of patients achieved SDS clinical response after 6 and 12 months of treatment, respectively.
    based on the Clinical General Impression Improvement Scale (CGI-I), clinicians reported rapid, significant and lasting improvements in depressive symptoms in patients treated with AXS-05.
    after receiving AXS-05 treatment, there was a significant or moderate improvement in depressive symptoms in 24.6% of patients in week 1, 48.5% in week 2, and 78.1% in week 6.
    improvement in CGI-I continued to be maintained or improved during long-term use of AXS-05 treatment: after 6 months and 12 months of treatment, significant or moderate improvement in depressive symptoms was achieved in 79.2% and 75.0% of patients, respectively.
    the test, the AXS-05 was well-to-do.
    the safety observed was consistent with previously reported in a controlled trial evaluating AXS-05 for the treatment of severe depression (MDD), with the most common adverse reactions being dizziness, nausea, headache, dry mouth and decreased appetite. Dr Herriot Tabuteau, chief executive of
    Axsome, said: "The data from the open label COMET-TRD trial show that AXS-05 has significant benefits for people with depression who have previously received two or more antidepressants that are ineffective and are notoriously difficult to treat.
    important is to receive AXS-05 treatment, and while depressive symptoms improve rapidly and continuously, the patient's function is improved rapidly and clinically.
    these results support the differentiated clinical characteristics of AXS-05 in depression treatment due to its novel glutamate mechanism.
    " original source: Axsome Therapeutics Announces Positive Results from the COMET-TRD Trial of AXS-05 in Patients with Treatment Resistant Depression
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