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Axsome Therapeutics

1. holenbeer 10 januari 2019 12:49

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   Dank je! Axsome had je goed gezien. Nu Acacia nog:-)
2. [verwijderd] 2 februari 2019 09:18

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   Ook van het US-forum
   everal hedge funds and other institutional investors have recently bought and sold shares of the stock. Alethea Capital Management LLC lifted its position in shares of Axsome Therapeutics by 65.9% during the 4th quarter. Alethea Capital Management LLC now owns 908,429 shares of the company’s stock worth $2,562,000 after purchasing an additional 360,986 shares during the last quarter. Worth Venture Partners LLC acquired a new position in shares of Axsome Therapeutics during the 3rd quarter worth about $138,000. Finally, Sio Capital Management LLC lifted its position in shares of Axsome Therapeutics by 115.5% during the 3rd quarter. Sio Capital Management LLC now owns 416,458 shares of the company’s stock worth $1,437,000 after purchasing an additional 223,168 shares during the last quarter.
   Helaas zonder bronvermelding
   
   Nieuws van 30 januari: Axsome Therapeutics Initiates Phase 2 Trial of AXS-12 in Narcolepsy
   
   finance.yahoo.com/news/axsome-therape...
   
   
3. [verwijderd] 2 februari 2019 09:23

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   clinicaltrials.gov/ct2/results?cond=&...
   
   Indrukwekkende pipeline voor zo'n relatief klein bedrijfje!!
   axsome.com/axs-pipeline/overview/
4. adri67 2 februari 2019 10:01

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   Venrock Healthcare Capital Partners Ii, L.p. discloses 5.00% ownership in AXSM / Axsome Therapeutics, Inc.
   
   January 28, 2019 - Venrock Healthcare Capital Partners Ii, L.p. has filed an SC 13G form with the Securities and Exchange Commission (SEC) disclosing ownership of 1,640,000 shares of Axsome Therapeutics, Inc. (NASDAQ:AXSM). This represents 5.0 percent ownership of the company.
5. [verwijderd] 2 februari 2019 10:22

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   quote:

   adri67 schreef op 2 februari 2019 10:01:

   Venrock Healthcare Capital Partners Ii, L.p. discloses 5.00% ownership in AXSM / Axsome Therapeutics, Inc.
   
   January 28, 2019 - Venrock Healthcare Capital Partners Ii, L.p. has filed an SC 13G form with the Securities and Exchange Commission (SEC) disclosing ownership of 1,640,000 shares of Axsome Therapeutics, Inc. (NASDAQ:AXSM). This represents 5.0 percent ownership of the company.
   

   Heb je daar nog een bron Adri?
6. [verwijderd] 2 februari 2019 11:00

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   Op de website van axsome staat over de pipeline niets meer vermeld over AXS-2
   (https://axsome.com/axs-pipeline/overview/)
   Terwijl bij de clinical trials er nog 2 onderzoeken hiervan in phase 3 zijn.
   (https://clinicaltrials.gov/ct2/show/NCT02746068?term=axsome&rank=4 en
   clinicaltrials.gov/ct2/show/NCT025040...
   Weet iemand daar iets meer van? Zijn die toch gestopt? Was dat vorig jaar 2 januari het nieuws dat die resultaten tegenvielen en de reden dat de koers ruim 30% naar beneden ging?
   
   Heb onderstaande gevonden:
   Axsome Therapeutics Announces AXS-02 Independent Data Monitoring Committee Recommends Continuation of COAST-1 Trial and Discontinuation of CREATE-1 Trial
   Bron: globenewswire.com/news-release/2018/0...
7. adri67 2 februari 2019 14:00

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   quote:

   GeldIsOokNietAlles schreef op 2 februari 2019 10:22:

   [...]
   
   Heb je daar nog een bron Adri?
   

   www.google.com/url?sa=t&rct=j&...
8. [verwijderd] 2 februari 2019 16:57

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   quote:

   adri67 schreef op 2 februari 2019 14:00:

   [...]
   www.google.com/url?sa=t&rct=j&...
   

   Thanks Adri, zo moeilijk was het inderdaad niet. Heb de vraag eigenlijk verkeerd gesteld. Ben op zoek naar een overzicht van alle institutionele partijen die in Axsome zitten.
9. [verwijderd] 2 februari 2019 17:00

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   Short Interest (Shares Short) 1,804,200
   Short Interest Ratio (Days To Cover) 0.2
   Short Percent of Float 8.70 %
   Short % Increase / Decrease 67 %
   Short Interest (Shares Short) - Prior 1,083,400
   Shares Float 20,749,400
   Trading Volume - Average 9,629,600
   Trading Volume - Today vs. Average 19.20%
   % Owned by Insiders 30.40%
   % Owned by Institutions 11.91%
   
   Bron: shortsqueeze.com/shortinterest/stock/...
10. [verwijderd] 6 februari 2019 09:58

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    Hoi Madeliefje, niet meer zo actief op IEX-forum?
    Heb gisteren plukje MEIP gekocht. De upside lijkt me idd veel groter dan de downside. Ik denk wel dat je gebruik moet maken van de euforie bij goed nieuws en dan uitstappen. Leuk al die deals die ze hebben maar "voor wat, hoort wat".
    Zit je nog steeds in AXSOME?
11. adri67 15 april 2019 22:39

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    Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Smoking Cessation
    GlobeNewswire•April 15, 2019
    
    Demonstrated statistically significant reduction in daily smoking compared to active comparator (p=0.0016)
    
    Trial conducted in collaboration with Duke University
    
    NEW YORK, April 15, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Duke University has completed its topline analysis of the Phase 2 trial of AXS-05 for smoking cessation treatment. The analysis showed that AXS-05 met the prespecified primary endpoint and significantly reduced daily smoking as compared to the active comparator bupropion. The trial was conducted at the Duke Center for Smoking Cessation under a research collaboration between Axsome and Duke University. The Phase 2 study was a randomized, double-blind, active-controlled trial, in which 58 adult smokers were treated either with AXS-05 (45 mg dextromethorphan/105 mg bupropion), or the active comparator bupropion (105 mg), twice daily, and assessed over a 3-week period.
    
    Treatment with AXS-05 resulted in a 25% greater reduction in the average number of cigarettes smoked per day over the 3-week period, the prespecified primary endpoint, as compared to bupropion (average reductions of 8.49 and 6.79 cigarettes per day for AXS-05 and bupropion, respectively, p=0.0016). Consistent with this finding, a greater proportion of smokers receiving AXS-05 experienced a more than 50% reduction in expired carbon monoxide levels, a biochemical marker of smoking intensity, as compared to those treated with bupropion (52.0% for AXS-05 versus 30.4% for bupropion, p=0.15). In addition, subjects who took AXS-05 as prescribed on a given day smoked 1.0 fewer cigarette on the day of medication use (p=0.026) and 1.2 fewer cigarettes on the following day (p=0.008) as compared to those who missed one or both doses.
    
    “The findings in this trial are notable because AXS-05 was compared to bupropion, an approved treatment for smoking cessation.” said James Davis, MD, Medical Director of the Duke Center for Smoking Cessation, and principal investigator of the trial. “The improvement of AXS-05 over bupropion observed in this trial is similar in magnitude to the improvement over placebo reported for the approved smoking cessation treatment varenicline in studies with a similar design. Reduction in ad-lib smoking was selected as the primary endpoint in this trial, because it has been shown to correlate with smoking abstinence. I look forward to the continued evaluation of AXS-05 as a smoking cessation treatment.”
    
    Medication adherence was similar between the study arms for both the morning dose (97.1% for AXS-05 and 96.6% for bupropion) and the evening dose (76.3% for AXS-05 and 79.4% for bupropion). In the study, AXS-05 was safe and well tolerated with no serious adverse events. The most commonly reported side effects were headache, dry mouth, and insomnia/vivid dreams, with similar incidences in both treatment arms.
    
    “The topline results of this Phase 2 trial in smoking cessation add to the growing body of clinical data demonstrating biologic activity for AXS-05 in different areas of unmet medical need including major depressive disorder,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We would like to thank the team at the Duke Center for Smoking Cessation for their collaboration with Axsome and for the execution of this important trial. We look forward to continuing to analyze these results with the team at Duke and to determining the next steps for this program.”
    
    “Smoking is widely recognized as the leading cause of preventable death and affects approximately 40 million adults in the U.S. alone,” said Cedric O’Gorman, MD, Senior Vice President of Clinical Development and Medical Affairs of Axsome. “Unfortunately, the vast majority of smokers who attempt to quit fail to do so highlighting the need for new approaches. We look forward to learning more about the potential of the novel mechanisms of action of AXS-05 to address this condition.”
    
    AXS-05 is a novel, oral, NMDA receptor antagonist, also known as a glutamate receptor modulator, a potentially new mechanism of action for smoking cessation treatment. AXS-05 consists of dextromethorphan and bupropion, and utilizes Axsome’s metabolic inhibition technology to increase the bioavailability of dextromethorphan. Both components of AXS-05 are nicotinic acetylcholine receptor antagonists, a mechanism that is relevant to nicotine dependence.
    
    About the Phase 2 Trial
    
    The trial was a Phase 2, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of AXS-05 for smoking cessation treatment. A total of 58 smokers were randomized in a 1:1 ratio to receive either AXS-05 (45 mg dextromethorphan/105 mg bupropion) (n=31), or bupropion (105 mg) (n=27), twice daily, and assessed over a 3-week period. Enrolled subjects were daily smokers using 10 or more cigarettes per day. The average number of cigarettes smoked per day at baseline was 20 for AXS-05 and 17 for the bupropion treatment groups. The primary outcome measure was the change in smoking intensity, measured using the number of cigarettes smoked per day, assessed via daily smoking diaries. The trial was conducted at the Duke Center for Smoking Cessation.
    
    About Smoking
    
    Nearly 40 million American adults smoke and around 70% report that they want to quit. Tobacco use results in approximately 500,000 premature deaths each year in the U.S., according to the Centers for Disease Control and Prevention. Smoking is the single largest cause of premature deaths worldwide accounting for an estimated almost 20% of all deaths in developed countries [1]. Direct health care and lost productivity costs as a result of smoking total nearly $300 billion a year in the U.S. alone. It is estimated that only 3 to 5% of cigarette smokers who attempt to quit without assistance are successful for 6 to 12 months, and that relapse rates remain above 80% even with current treatments [2].
    
    About AXS-05
    
    AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of central nervous system (CNS) disorders. AXS-05 consists of dextromethorphan and bupropion and utilizes Axsome’s metabolic inhibition technology. The dextromethorphan component of AXS-05 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a glutamate receptor modulator, which is a novel mechanism of action, meaning it works differently than currently available therapies for depression. The dextromethorphan component of AXS-05 is also a sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is covered by more than 30 issued U.S. and international patents which provide protection out to 2034. AXS-05 is not approved by the FDA.
12. adri67 19 mei 2019 21:12

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    Here's Why You'll Regret Ignoring This Biotech Stock Rocket
    Cory Renauer, The Motley Fool
    
    Motley Fool • May 19, 2019
    
    Taking two old drugs and combining them to treat depression was a roll of the dice that hardly anyone paid attention to during Axsome Therapeutics' (NASDAQ: AXSM) first few years as a publicly traded drugmaker. Clearly, that was a mistake.
    
    At the beginning of 2019, this clinical-stage biotech was worth just under $80 million because its lead candidate seemed a little ridiculous. Since then, the stock has risen sevenfold and it's just getting started. Here's why you'll regret turning up your nose at Axsome in a few years, and probably a lot sooner.
    
    So what if it's simple?
    
    Axsome's lead candidate, AXS-05, is simply a combination of bupropion and dextromethorphan, two well-known drugs that make a dangerous combination because they amplify each other's effects. Bupropion is a norepinephrine and dopamine reuptake inhibitor that's been used to treat depression under the name Wellbutrin for decades. More recently, bupropion's been used as a smoking-cessation aid branded as Zyban, and off-label for attention-deficit hyperactivity disorder.
    
    Bupropion's isn't nearly as common as dextromethorphan, a drug that nearly everyone has taken before and will probably take again. If you've swallowed anything to suppress a cough, it probably contained dextromethorphan, but that's not its only use. It's also a commonly abused over-the-counter medication that happens to amplify the effects of bupropion.
    
    In fact, when someone regularly taking bupropion for depression, smoking cessation, or ADHD happens to chug a bottle of cough syrup, that person can end up in the hospital, or worse.
    
    Major depressive disorder (MDD) affects around 6.7% of American adults, and available antidepressants aren't enough to break through for around one-third of them. Taking advantage of the interaction between the two drugs and finding the right balance seems obvious in retrospect, but Axsome was the first to combine a relatively small amount of both into a single tablet.
    
    Beyond all expectations
    
    Everyone who thought about boosting the power of bupropion with a measured dose of cough syrup but never did anything about it must be kicking himself right now. Few were paying attention to Axsome this January, but those who were had their minds blown.
    
    During the phase 2 Ascend study, AXS-05 helped 47% of patients with MDD achieve clinical remission, compared with just 16% of patients in the group given bupropion on its own. The increased benefit isn't limited to depression, either. The amplification appears to carry over to bupropion's use as a smoking-cessation aid. During a 58-patient study, those taking AXS-05 smoked significantly less than those given bupropion on its own.
    Axsome's ball to drop
    
    During midstage studies, AXS-05 appeared just as safe and tolerable as bupropion monotherapy. Using two well-known drugs may not win awards for innovation, but it could help Axsome race along the path from a clinical-stage drugmaker to one with a product to sell. That's because the FDA is practically pushing the sorely needed new treatment option through the late-stage development process.
    
    The FDA appears willing to accept a new drug application for the treatment of MDD based on results from the completed 80-patient Ascend study, instead of waiting for an ongoing phase 3 trial to wrap up. Unless Axsome forgets to include something in its new drug application, the company could receive an expedited review of AXS-05 and launch the potential blockbuster in the first half of 2020.
    
    We have no idea where Axsome will price AXS-05, but it probably won't need to rely on an exorbitant sum to drive several billion in annual sales within a few short years. In the U.S. alone, there are roughly 7 million people suffering from treatment-resistant MDD, and they're clamoring for a better treatment option.
    
    More on the way?
    
    Axsome did so well with dextromethorphan and bupropion that it's ready to try another combination for the treatment of migraine headaches, and it's roaring forward at top speed. Before the end of the year, we could have phase 3 trial results for AXS-07, another combination of well-known drugs.
    
    Rizatriptan is a powerful headache pain reliever that contracts blood vessels in the head, but it doesn't work for everyone. Meloxicam is a prescription-strength non-steroidal anti-inflammatory usually used to relieve arthritis symptoms.
    
    After meeting with the FDA, Axsome is confident it can earn approval for AXS-07 without any early clinical-stage data -- just a single phase 3 trial should be enough. The phase 3 Momentum study has already finished enrolling people that don't respond to existing migraine pain relievers including rizatriptan.
    
    We should be able to see results from the 875-patient Momentum trial before the end of 2019, which means Axsome could launch a second product for millions of underserved patients less than a year after AXS-05 reaches pharmacy shelves.
    More fuel in the tank
    
    Axsome Therapeutics stock has already soared 737% since the beginning of 2019, but its market cap is still just $786 million at recent prices. Drugmaker stocks generally trade at mid-single-digit multiples of trailing sales. With the FDA bending over backward to the company launch two potential blockbusters as quickly as possible, this stock probably has a lot more room to run over the next few years.
    
13. [verwijderd] 13 juni 2019 12:38

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    Weer inside buy
    www.nasdaq.com/symbol/axsm/insider-tr...
    
    shorters weer 9% uitgebreid afgelopen 2 weken
    shortsqueeze.com/shortinterest/stock/...
    
    Dat is meer dan 50% van de freefloat (als je de freefloat in handen van instituties niet meetelt)
14. adri67 16 december 2019 14:18

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    Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in GEMINI Phase 3 Trial in Major Depressive Disorder
    GlobeNewswire • December 16, 2019
    
    Demonstrated rapid, durable, and statistically significant improvement in depressive symptoms as measured by MADRS total score compared to placebo (p=0.002 on primary endpoint)
    
    Statistically significant improvement at week 1 in MADRS total score compared to placebo (key secondary endpoint, p=0.007)
    
    Statistically significant improvement versus placebo on all secondary endpoints at week 6, including remission (p<0.001), disease severity (p=0.002), functional impairment (p=0.002), and quality of life (p=0.011)
    
    Positive results support NDA filing of AXS-05 for MDD, anticipated in 2H 2020
    
    Potentially first-and-only, oral NMDA receptor antagonist with multimodal activity for the treatment of depression
    
    Company to host conference call today at 8:00 AM ET
    
    NEW YORK, Dec. 16, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary endpoint and rapidly and significantly improved symptoms of depression in the GEMINI Phase 3 trial in major depressive disorder (MDD). The GEMINI study was a randomized, double-blind, placebo-controlled, multi-center, U.S. trial, in which 327 adult patients with confirmed moderate to severe MDD were randomized to treatment with either AXS-05 (dextromethorphan/bupropion modulated delivery tablet) or placebo once daily for the first 3 days and twice daily thereafter for a total of 6 weeks.
    
    AXS-05 met the primary endpoint by demonstrating a highly statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo at Week 6, with mean reductions from baseline of 16.6 points for AXS-05 and 11.9 points for placebo (p=0.002). AXS-05 rapidly and durably improved depressive symptoms as compared to placebo with statistical significance on the MADRS total score demonstrated at Week 1, the earliest time point assessed, and at all time points thereafter. Rates of remission from depression (defined as MADRS =10) were statistically significantly greater for AXS-05 compared to placebo at Week 2 (p=0.013) and at every time point thereafter, being achieved by 39.5% of AXS-05 patients compared to 17.3% of placebo patients at Week 6 (p<0.001).
    
    AXS-05 demonstrated rapid onset of action with statistically significant improvement as compared to placebo on numerous endpoints at Week 1, or only 4 days after the start of twice daily dosing. Statistically significant improvements at Week 1 were observed for MADRS total score (key secondary endpoint, p=0.007); Patient Global Impression-Improvement (PGI-I) (p=0.008); Clinical Global Impression-Severity (CGI-S) (p=0.013); Clinical Global Impression-Improvement (CGI-I) (p=0.035); Quick Inventory of Depressive Symptomatology-Self-Rated (QIDS-SR-16) (p=0.016); Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) (p=0.031); and other endpoints.
    
    On all secondary endpoints including the following, AXS-05 demonstrated statistically significant improvement at Week 6 compared to placebo, reflecting increasing treatment effects over time: clinical response on the MADRS total score (defined as =50%) (p<0.001); PGI-I (p=0.007); CGI-S (p=0.002); CGI-I (p=0.016); QIDS-SR-16 (p=0.001); Sheehan Disability Scale (SDS) (p=0.002); and Q-LES-Q-SF (p=0.011).
    
    "AXS-05 demonstrated a rapid and very clinically meaningful improvement in depressive symptoms, observed after only one week, in this large and well-controlled Phase 3 trial in major depressive disorder. Given the known challenges of conducting trials in psychiatry, it is very encouraging to see replication of Phase 2 findings in such a robust way,” said Professor Maurizio Fava, MD, Psychiatrist-in-Chief at Massachusetts General Hospital (MGH), Director of the Division of Clinical Research of the MGH Research Institute, and Associate Dean for Clinical & Translational Research at Harvard Medical School. “Clinical depression is a potentially life-threatening condition. Currently marketed antidepressants fail to provide adequate treatment response in almost two thirds of treated patients, and may take up to six to eight weeks to provide clinically meaningful response. These data suggest that AXS-05, as an oral NMDA receptor antagonist with multimodal activity, may represent a novel treatment for major depressive disorder.”
    
    AXS-05 was well tolerated in the trial. The most commonly reported adverse events in the AXS-05 arm were dizziness, nausea, headache, diarrhea, somnolence, and dry mouth. There was one serious adverse event in the AXS-05 arm which was deemed by the investigator not to be study-drug related. The rates of discontinuation due to adverse events were low in both treatment groups (6.2% for AXS-05 and 0.6% for placebo). Treatment with AXS-05 was not associated with psychotomimetic effects or weight gain.
    
    “We are very pleased with the compelling results of the GEMINI trial which demonstrate the potential for AXS-05 to provide significant benefits to patients living with depression, based on observed rapid and sustained antidepressant effects, resulting from its potentially first-in-class, oral NMDA receptor antagonist and multimodal mechanism of action,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “The progress of the AXS-05 clinical program in mood disorders reflects Axsome’s commitment to accelerating innovation to address serious CNS disorders. With GEMINI and the previously completed ASCEND study, the efficacy of AXS-05 in major depressive disorder has now been demonstrated in two positive well-controlled trials, enabling the filing of an NDA for AXS-05, which is anticipated in the coming year.”
    
    AXS-05 was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of MDD in March 2019. Based on the outcome of the FDA Breakthrough Therapy meeting, Axsome believes the positive results of the GEMINI trial, along with the previously completed ASCEND trial of AXS-05 in MDD, are sufficient to support submission of a New Drug Application (NDA) for AXS-05 for the treatment of MDD. Axsome plans to file the NDA in the second half of 2020.
    
    “Depression is a major public health concern with most patients failing to adequately respond to currently approved antidepressants,” said Cedric O’Gorman, MD, Senior Vice President of Clinical Development and Medical Affairs of Axsome. “The potentially fatal consequences of depression highlight the need to rapidly and effectively control depressive symptoms. The positive results of the GEMINI study are significant and exciting because they bring us closer to our goal of addressing this public health need with a potentially first-in-class, rapid-acting, effective, oral, antidepressant which can be safely administered at home. With its modulation of glutamate neurotransmission, if approved, AXS-05 would represent the first mechanistically novel oral pharmacotherapy for depression in over 30 years.”
15. adri67 16 december 2019 14:21

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    AXS-05 is a novel, oral, non-competitive NMDA receptor antagonist, also known as a glutamate receptor modulator, a new mechanism of action which is thought to help enhance synaptic connections and improve the communication between brain cells in people with major depressive disorder. In addition, AXS-05 is a sigma-1 receptor agonist; enhances brain levels of serotonin, noradrenaline, and dopamine, which are key neurotransmitters involved in the regulation of mood; and displays anti-inflammatory properties, which may be relevant to treating MDD. The multimodal actions of AXS-05 may be complementary and synergistic for the treatment of this biologically-based condition. AXS-05 is covered by 41 issued U.S. and international patents providing protection out to 2034, and Axsome maintains worldwide rights.
    
    Detailed study results, including additional secondary endpoints, will be submitted for presentation at upcoming medical meetings and for publication. AXS-05 is also being evaluated in the STRIDE-1 Phase 3 trial in patients with treatment resistant depression (TRD), defined as patients with MDD who have failed two or more antidepressant treatments, and in the ADVANCE-1 trial in patients with Alzheimer’s disease agitation. AXS-05 was granted Fast Track designations by the FDA for the treatment of TRD and for the treatment of Alzheimer’s disease agitation.
    
    Summary of Topline Results of the GEMINI Trial
    
    Effect on Depressive Symptoms
    
    AXS-05 was associated with a statistically significant mean reduction from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 16.6 points for AXS-05 compared to 11.9 for placebo at Week 6 (p=0.002).
    
    Remission, an absence of clinically significant symptoms of depression, prospectively defined as a MADRS total score of =10, was seen at Week 6 in 39.5% of patients who received AXS-05, compared to 17.3% of patients who received placebo (p<0.001).
    
    Response, defined as a =50% improvement in the MADRS total score, was seen at Week 6 in 54.0% of patients who received AXS-05, compared to 34.0% of patients who received placebo (p<0.001).
    
    All secondary endpoints improved in favor of AXS-05 and achieved statistical significance at Week 6 (e.g. PGI-I, CGI-S, CGI-I, QIDS-SR-16, MADRS-6, etc.).
    
    Time Course of Effect on Depressive Symptoms
    
    AXS-05 demonstrated a statistically significant mean reduction from baseline in the MADRS total score of 7.3 points for AXS-05 compared to 4.9 points for placebo at Week 1 (p=0.007), with statistical significance for this measure maintained at all time points thereafter.
    
    Statistically significant improvements at Week 1 were also observed for the PGI-I (p=0.008), CGI-S (p=0.013), CGI-I (p=0.035), QIDS-SR-16 (p=0.016), MADRS-6 (p=0.019), and other endpoints. Statistically significant effects on these measures were generally maintained at all time points thereafter.
    
    Remission rates were statistically significantly greater for AXS-05 as compared to placebo at Week 2 (p=0.013) and at every time point thereafter.
    
    Quality of Life and Functional Impairment
    
    AXS-05 was associated with a statistically significant improvement in quality of life, as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), compared to placebo at Week 1 (p=0.031), and at every time point thereafter (p=0.011, at Week 6).
    
    AXS-05 was associated with a statistically significant reduction in functional impairment, as measured by the Sheehan Disability Scale (SDS), compared to placebo at Week 2 (p=0.003), and at every time point thereafter (p=0.002, at Week 6).
    
    Safety and Tolerability
    
    AXS-05 was well tolerated in the trial.
    
    The most commonly reported adverse events in the AXS-05 arm were dizziness, nausea, headache, diarrhea, somnolence, and dry mouth. There was one serious adverse event in the AXS-05 arm which was deemed by the investigator not to be study-drug related.
    
    The rates of discontinuation due to adverse events were low in both treatment groups (6.2% for AXS-05 and 0.6% for placebo).
    
    Treatment with AXS-05 was not associated with psychotomimetic effects or weight gain.
    
    
16. Morgoth 26 april 2021 12:34

    auteur info

    • Morgoth

      Lid sinds: 10 jun 2020

      Laatste bezoek: 05 jul 2024

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    axsometherapeuticsinc.gcs-web.com/new...
    
    Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder
    FDA grants Priority Review and sets PDUFA action goal date of August 22, 2021
    
    Eindelijk dus nog wat goed nieuws... op naar augustus! GLTA!