AXSM - Axsome Therapeutics Highlights Commitment to Innovating Treatments for Mental Health Conditions with Presentations at Psych Congress 2023 | Benzinga
Data presentations explore effects on patient-centric efficacy measures of treatments for patients with depression, and excessive sleepiness associated with obstructive sleep apnea and narcolepsy
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.
"Axsome's presentations at Psych Congress highlight our commitment to advancing research of medicines that have the potential to improve the lives of patients with brain health conditions such as depression and sleep disorders," said Cecilia Brain, MD, PhD, Vice President of Medical Affairs at Axsome. "These presentations explore the meaningful impact that our treatments could have for patients and underscore the unique pharmacology of our novel medicines which may be relevant to multiple clinical conditions."
The presentations will include eight posters with data and analyses which examine the effects of AUVELITY® (dextromethorphan-bupropion) on sleep quality and cognitive and physical functioning in patients with major depressive disorder (MDD), and the effects of SUNOSI® (solriamfetol) on cognition in patients with excessive daytime sleepiness (EDS) due to obstructive sleep apnea (OSA). Five of the eight posters are finalists under consideration for the Psych Congress Poster Awards.
Key highlights include:
- Data examining durability of efficacy and tolerability with long-term (up to 12 months) treatment with AUVELITY in patients with MDD, including measures of depressive symptoms, anxiety, and cognitive and physical functioning.
- Data examining the effect of AUVELITY on depression-related disability, and patient-reported measures of insomnia in patients with MDD.
- Data examining treatment effect sizes of SUNOSI in patients with EDS associated with narcolepsy and OSA.
- Data examining the effects of SUNOSI on cognition in patients with EDS and OSA.
All posters will be presented on September 8 and 9 from 1:30-3 p.m. Central Time in Exhibit Hall A and B. An asterisk ahead of the title (*) indicates presentations under consideration as finalists for the Psych Congress Poster Awards, being presented from 6:45-8 p.m. Central Time on September 9. Details for the presentations are as follows:
Major Depressive Disorder:
* Title: AXS-05 (Dextromethorphan-Bupropion) Significantly Improved Functioning in Major Depressive Disorder: Analysis of the Domains of the Sheehan Disability Scale
Lead Author: Andrew Cutler, MD, SUNY Upstate Medical University and Neuroscience Education Institute
Poster Number: 44
* Title: Improvements in Cognitive and Physical Functioning Outcomes in Depressed Individuals Treated with AXS-05 (Dextromethorphan-Bupropion): Results from the EVOLVE Open-Label, Long-Term Study
Lead Author: Maurizio Fava, MD, Director, Division of Clinical Research, Massachusetts General Hospital (MGH) Research Institute
Poster Number: 51
Title: Assessment of Withdrawal Symptoms After Discontinuation of AXS-05 (Dextromethorphan-Bupropion) Treatment: Results From the GEMINI Trial
Lead Author: Rakesh Jain, MD, Texas Tech University School of Medicine-Permian Basin
Poster Number: 71
Title: Impact of AXS-05 (Dextromethorphan-Bupropion) on Patient-Reported Insomnia Symptoms: Results From the GEMINI Trial
Lead Author: Manish Jha, MD, O'Donnell Clinical Neuroscience Scholar Center for Depression Research and Clinical Care
Poster Number: 73
Excessive Daytime Sleepiness in Obstructive Sleep Apnea and Narcolepsy:
* Title: Effects of Solriamfetol on Cognitive Function in Participants With Cognitive Impairment Associated With Excessive Daytime Sleepiness in Obstructive Sleep Apnea: Results of the SHARP Study
Lead Author: Hans Van Dongen, PhD, Washington State University
Poster Number: 32
* Title: Solriamfetol Improves Cognitive Performance in Preclinical Models of Sleep Apnea and in a Randomized Placebo-Controlled Study of Sleep Apnea Participants (SHARP)
Lead Author: David Gozal, MD, University of Missouri
Poster Number: 33
* Title: Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm
Lead Author: Craig Chepke, MD, SUNY Upstate Medical University
Poster Number: 45
Title: SURWEY Study of Solriamfetol: Initiation, Titration, Safety, Efficacy, and Follow-Up Experience for Patients With OSA in Germany
Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany
Poster Number: 99
INDICATION AND IMPORTANT SAFETY INFORMATION
WHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to treat adults with major depressive disorder (MDD). It is not known if Auvelity is safe and effective for use in children.
Auvelity is not approved for uses other than the treatment of MDD. The ingredients in Auvelity, bupropion and dextromethorphan, are the same ingredients found in some other medicines approved for other uses.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY?
Auvelity and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. Auvelity is not for use in children.
You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine.
Call your healthcare provider (HCP) or get emergency help right away if you or your loved one have any of the following symptoms, especially if they are new, worse, or worry you:
- suicidal thoughts or actions
- new or worsening depression or anxiety
- agitation or restlessness
- trouble sleeping (insomnia)
- acting aggressive, being angry violent
- an extreme increase in activity and talking (mania)
- panic attacks
- new or worsening irritability
- acting on dangerous impulses
- other unusual changes in behavior or mood
Do not take Auvelity if you:
- have or had a seizure disorder.
- have or had an eating disorder like anorexia or bulimia.
- have ...