Solriamfetol

Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2023 Net Revenue and 2024 Anticipated Milestones

Retrieved on: 
Thursday, January 4, 2024
Migraine, Dextromethorphan/bupropion, Binge eating disorder, DSM-IV codes, NDA, Brain, MD, Therapy, Clinical trial, Solriamfetol, FOCUS, SYMPHONY, Fibromyalgia, CNS, Prescription, Central nervous system, Patient, ADHD, Narcolepsy, Somnolence, Pharmaceutical industry

“Axsome completed its first full year as a commercial company in 2023 and, during that time, our medicines reached approximately 100,000 unique patients.

Key Points: 
  • “Axsome completed its first full year as a commercial company in 2023 and, during that time, our medicines reached approximately 100,000 unique patients.
  • Auvelity® net product sales are expected to be approximately $49 million and $130 million for the fourth quarter and full year of 2023, respectively.
  • Sunosi® net product revenue is expected to be $22 million and $74 million for the fourth quarter and full year of 2023, respectively.
  • Net product revenue excludes $66 million in license revenue recognized by Axsome in the first quarter of 2023.

Axsome Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 6, 2023
Shift, Research, AD, Food, Medicare, FOCUS, Narcolepsy, Doctor of Philosophy, Fibromyalgia, Prescription, New Drug Application, Agitation, Shift work, Shirin David, Physician, SG, Acquisition, Smoking, Amgen, Webcast, Somnolence, NDA, Safety, Therapy, Patient, Food and Drug Administration, Central nervous system, Eli Lilly and Company, Reboxetine, SWD, ES, MD, Migraine, Growth, Binge eating disorder, Breakthrough therapy, Total, FDA, Government, SYMPHONY, CMC, CNS, R, DSM-IV codes, Horizon Therapeutics, BED, Dextromethorphan/bupropion, NMDA, Eating disorder, Beauty salon, Video game, Pharmaceutical industry, Bank, Dietary supplement, Solriamfetol, ADHD, Medicaid

“Results for the third quarter evidenced significant revenue momentum for Axsome driven by solid performance from both Auvelity and Sunosi.

Key Points: 
  • “Results for the third quarter evidenced significant revenue momentum for Axsome driven by solid performance from both Auvelity and Sunosi.
  • Auvelity® net product sales were $37.7 million for the third quarter of 2023, representing a 36% sequential increase versus the second quarter of 2023.
  • Third quarter 2023 U.S. Sunosi total prescriptions increased by 16% versus the third quarter of 2022, and sequentially by 5% versus the second quarter of 2023.
  • Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss third quarter 2023 financial results as well as to provide a corporate update.

Axsome Therapeutics Highlights Commitment to Innovating Treatments for Mental Health Conditions with Presentations at Psych Congress 2023

Retrieved on: 
Thursday, September 7, 2023
Blood pressure, Psychiatry, MAOI, Pregnancy, Depression, Psychosis, Heart failure, Medication, Eating disorder, Diarrhea, Suicide, Xerostomia, Anxiety, Spinal cord, Stroke, Brain, Medicine, Psychological abuse, History, HCP, Tablet, Vitamin, Insomnia, Dizziness, Risk, Perspiration, Liver, Neoplasm, Heart rate, Head injury, Headache, Death, Irritability, Agitation, Bipolar disorder, Breast milk, DSM-IV codes, Birth control, Pharmaceutical industry, Dietary supplement, Drug, Liquor, Residential care, Health insurance, Solriamfetol, Mental, Dextromethorphan/bupropion

NEW YORK, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations of data from its CNS portfolio at the 2023 U.S. Psych Congress, being held in Nashville, Tenn. from September 6-10. The presentations demonstrate the Company’s commitment to continued innovation to address unmet needs in difficult-to-treat CNS disorders.

Key Points: 
  • Tell your HCP about all your medical conditions, including if you:
    have problems with your liver or kidneys.
  • have a history of seizure, stroke, eating disorder, head injury, or have a tumor in your brain or spinal cord.
  • have a history of mental health problems (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction.
  • Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI.

Axsome Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 7, 2023
Shift, Total, Migraine, Central nervous system, Narcolepsy, SG, SWD, Eating disorder, Binge eating disorder, FOCUS, New Drug Application, Food and Drug Administration, DCC, NDA, Prescription, NMDA, SYMPHONY, CNS, Government, ES, Medicare, Breakthrough therapy, MD, Physician, Patient, Esreboxetine, Reboxetine, BED, Fibromyalgia, Somnolence, Webcast, R, Research, AD, FDA, Therapy, Smoking, Dextromethorphan/bupropion, Agitation, Food, Safety, Pharmaceutical industry, Video game, Bank, Security (finance), Dietary supplement, Medicaid, Solriamfetol, ADHD

Auvelity® net product sales were $27.6 million for the second quarter of 2023, representing a 76% sequential increase versus the first quarter of 2023.

Key Points: 
  • Auvelity® net product sales were $27.6 million for the second quarter of 2023, representing a 76% sequential increase versus the first quarter of 2023.
  • Approximately 53,000 prescriptions were reported for Auvelity in the second quarter of 2023, representing a 72% sequential increase versus the first quarter of 2023.
  • Second quarter 2023 U.S. Sunosi total prescriptions increased by 15% versus the second quarter of 2022, and sequentially by 8% versus the first quarter of 2023.
  • Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss first quarter 2023 financial results as well as to provide a corporate update.

Axsome Therapeutics to Present New Sunosi® Data at SLEEP 2023

Retrieved on: 
Thursday, June 1, 2023
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NEW YORK, June 01, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations on Sunosi® (solriamfetol) at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society, being held in Indianapolis, Ind., from June 3-7, 2023.

Key Points: 
  • NEW YORK, June 01, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations on Sunosi® (solriamfetol) at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society, being held in Indianapolis, Ind., from June 3-7, 2023.
  • The presentations include new data from the SHARP (Solriamfetol’s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled) study in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA), demonstrating sustained improvement with Sunosi on measures of cognition across 8-hours with once daily dosing.
  • Additional new data and analyses include real-world data from OSA patients taking Sunosi as part of the SURWEY study in Germany, healthcare resource use in OSA patients with residual EDS, and effect sizes and numbers needed to treat analyses.
  • “Cognitive impairment is a substantial burden to many patients with EDS and OSA.

Axsome Therapeutics to Present Data and Post-Hoc Analyses on Auvelity® and Sunosi® at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Retrieved on: 
Tuesday, May 30, 2023
Presenteeism, Major depressive disorder, Central nervous system, Solriamfetol, Obstructive sleep apnea, Somnolence, State University of New York Upstate Medical University, EDS, Narcolepsy, Disability, Functional disorder, OSA, CNS, ASCP, Drug, MDD, MD, Patient, Domain, Ontario Prehospital Advanced Life Support Studies, Randomness, Medication discontinuation, Annual general meeting, Magnetic resonance, United, Therapy, SHARP, Society, Dextromethorphan/bupropion, Cognitive deficit, Pharmaceutical industry, Medical device, Apnea

NEW YORK, May 30, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations on Auvelity® (dextromethorphan-bupropion), Sunosi® (solriamfetol), and disease state at the upcoming American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held from May 30-June 3 in Miami. The presentations on Auvelity incorporate new data and post-hoc analyses including demonstration of functional improvement in patients with major depressive disorder (MDD). The presentations on Sunosi include data from the SHARP (Solriamfetol’s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled) study demonstrating improvement in cognitive function in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA).

Key Points: 
  • NEW YORK, May 30, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations on Auvelity® (dextromethorphan-bupropion), Sunosi® (solriamfetol), and disease state at the upcoming American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held from May 30-June 3 in Miami.
  • The presentations on Auvelity incorporate new data and post-hoc analyses including demonstration of functional improvement in patients with major depressive disorder (MDD).
  • The presentations on Sunosi include data from the SHARP (Solriamfetol’s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled) study demonstrating improvement in cognitive function in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA).
  • “MDD is the leading cause of disability worldwide and improvement in functioning is critically important to people with MDD.

Axsome Therapeutics Reports First Quarter 2023 Financial Results and Corporate Update

Retrieved on: 
Monday, May 8, 2023
Total, Migraine, Narcolepsy, Central nervous system, SG, New Drug Application, Food and Drug Administration, NDA, ADHD, Prescription, NMDA, SYMPHONY, Research, CNS, HCP, Government, Medicare, Breakthrough therapy, Acquisition, DSM-IV codes, MD, Patient, Reboxetine, Somnolence, Fibromyalgia, Webcast, R, AD, FDA, Therapy, Obstructive sleep apnea, Dextromethorphan/bupropion, Smoking, Agitation, Food, Safety, Pharmaceutical industry, Video game, Cryptocurrency, Bank, Health insurance, Dietary supplement, Medicaid, Solriamfetol

NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the first quarter ended March 31, 2023.

Key Points: 
  • “The first quarter of 2023 was another important milestone for Axsome as it marked the first full quarter of launch for Auvelity.
  • Sunosi net product sales were $12.9 million for the first quarter of 2023, including $1.7 million in international net sales booked by Axsome.
  • The first quarter of 2023 was the first full quarter of sales for Auvelity, which was launched in October 2022.
  • Phase 3 SYMPHONY trial of AXS-12 in narcolepsy, topline data (2Q 2023)
    Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss first quarter 2023 financial results as well as to provide a corporate update.

Axsome Therapeutics to Present Five Abstracts Including New Data from the Positive SHARP Study of SUNOSI® (solriamfetol) in Participants with Cognitive Impairment with Excessive Daytime Sleepiness in Obstructive Sleep Apnea at the 2023 American Academy of

Retrieved on: 
Friday, April 21, 2023
Abstract, Migraine, Narcolepsy, Central nervous system, University, Obstructive sleep apnea, Somnolence, EDS, AAN, Deficit spending, TAAR1, American Academy, OSA, CNS, Patient, Annual general meeting, Magnetic resonance, Cognitive deficit, Therapy, SHARP, Washington State University, American Academy of Neurology, Pharmaceutical industry, Solriamfetol, Safety

NEW YORK, April 21, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will be presenting five abstracts at the upcoming 2023 American Academy of Neurology (AAN) Annual Meeting, being held from April 22-27 in Boston.

Key Points: 
  • NEW YORK, April 21, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will be presenting five abstracts at the upcoming 2023 American Academy of Neurology (AAN) Annual Meeting, being held from April 22-27 in Boston.
  • These presentations include new data from the SHARP study, a randomized, double-blind, placebo-controlled, crossover, multicenter trial in 59 patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) and impaired cognitive function, from which positive topline results were announced in October 20221.
  • “The SHARP study is exciting because it overcomes treatment barriers associated with the complex relationship between cognitive impairment and OSA,” said Hans Van Dongen, Ph.D., Professor at Washington State University and first author of the SHARP study abstract.
  • “Endpoints from the SHARP study show potential clinical benefit for patients taking solriamfetol versus placebo, suggesting it can be a robust option for the treatment of patients with EDS due to OSA.

Axsome Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Monday, February 27, 2023
SHARP, Safety, Therapy, SG, Central nervous system, Patient, MD, Migraine, Fibromyalgia, Narcolepsy, Depression, Medicaid, Research, Acquisition, SYMPHONY, Webcast, FDA, New Drug Application, R, CNS, NMDA, NDA, Reading, Medicare, Reboxetine, DSST, Somnolence, Obstructive sleep apnea, Food and Drug Administration, ADHD, HCP, MENA, ACCORD, GPO, Smoking, Food, Breakthrough therapy, Agitation, Pharmaceutical industry, Video game, Cryptocurrency, Health insurance, Dietary supplement, Solriamfetol, Dextromethorphan/bupropion, EU

Auvelity was launched on October 19, 2022 and had U.S. net sales of $5.2 million for the fourth quarter of 2022.

Key Points: 
  • Auvelity was launched on October 19, 2022 and had U.S. net sales of $5.2 million for the fourth quarter of 2022.
  • Net sales of Sunosi to Axsome were $19.2 million and $44.8 million for the fourth quarter and full year of 2022 respectively.
  • Axsome began selling Sunosi in the U.S. in May 2022 and in certain international markets in November 2022.
  • Fourth quarter U.S. Sunosi total prescriptions increased by 11% versus the fourth quarter of 2021, and by 1% versus the third quarter of 2022.

Axsome Therapeutics Enters into License Agreement with Pharmanovia to Expand Commercialization and Further Develop Sunosi® (solriamfetol) in Europe

Retrieved on: 
Wednesday, February 22, 2023
Marketing, Safety, Therapy, OSA, Central nervous system, MD, EDS, LLP, Morgan Stanley, Narcolepsy, European Medicines Agency, Patient, CNS, Dopamine, Wakefulness, EMA, Obstructive sleep apnea, DLA Piper, Pharmaceutical industry, Solriamfetol

NEW YORK, Feb. 22, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it has entered into an exclusive license agreement with Pharmanovia to commercialize and further develop Sunosi® (solriamfetol), the first and only dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA), in Europe and certain countries in the Middle East and North Africa (MENA).

Key Points: 
  • Under the terms of the agreement, Pharmanovia will be responsible for marketing Sunosi in Europe and MENA regions and will assume responsibility for all local clinical and regulatory activities and requirements including studies in pediatric patients.
  • Axsome will receive an upfront payment of $66 million and is eligible to receive sales-based and other milestones totaling up to $101 million.
  • Axsome will receive a royalty percentage in the mid-twenties on net sales.
  • We are delighted to partner with Axsome, a leading CNS-focused biopharmaceutical company, and to expand the overseas launch and further the clinical development of Sunosi.