In an announcement on May 28, 2024, Axsome Therapeutics, Inc. (NASDAQ: AXSM), a company specializing in the development of innovative treatments for central nervous system (CNS) disorders, revealed that it will present new data from its CNS product portfolio at the upcoming 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami Beach, Florida. The event, taking place from May 28 to May 31, will showcase post-hoc analyses of Auvelity® and clinical data on AXS-05 for Alzheimer’s disease agitation.
Notably, two presentations will highlight the effects of AXS-05 (a combination of dextromethorphan and bupropion) in major depressive disorder (MDD). At the ASCP meeting, the first study will focus on how AXS-05 improves anhedonia and interest-activity symptoms in MDD patients, correlating these improvements with functional impairment reduction. This presentation will be led by Dr. Roger McIntyre, a Psychiatry and Pharmacology Professor at the University of Toronto, on May 29 between 11:15 a.m. and 1 p.m. The second study, presented by Dr. Andrew Muzyk from Duke University, will examine real-world patient characteristics in MDD treated with AXS-05, scheduled for the same time slot.
In the realm of Alzheimer's disease, a critical presentation will discuss the clinical profile of AXS-05 in treating agitation associated with Alzheimer's disease. This session, also slated for May 29 from 11:15 a.m. to 1 p.m., will be presented by Dr. Jeffrey Cummings from the UNLV Department of Brain Health.
Another key presentation involves the cognitive performance benefits of Solriamfetol in preclinical models of sleep apnea and a randomized placebo-controlled study (SHARP). David Gozal, MD, MBA, from the University of Missouri will lead this session on May 30 from 12:30 p.m. to 2:15 p.m.
Auvelity®, a novel treatment for MDD in adults, will be prominently featured. As an NMDA receptor antagonist, Auvelity is designed to modulate glutamatergic neurotransmission through its dextromethorphan component, while the bupropion component helps maintain its blood levels. Despite these advancements, the precise mechanism of Auvelity remains unclear. The drug comes with FDA Breakthrough Therapy designation and has a variety of safety considerations, including potential for increased suicidal thoughts and actions in younger populations, particularly when treatment begins or dosages change.
Patients should be mindful of possible side effects such as dizziness, blood pressure increases, and manic episodes, particularly in those with bipolar disorder. Auvelity should not be used by individuals with certain medical conditions like seizure disorders or those taking specific medications, including MAOIs. The combination of bupropion and dextromethorphan also poses risks of unusual thoughts, delusions, and serotonin syndrome when combined with other drugs.
Patients are advised to closely follow dosage instructions, take the medication as prescribed, and consult their healthcare provider before making any changes to their treatment plan. Pregnant or breastfeeding women should avoid Auvelity due to potential harm to the unborn or nursing baby.
Axsome Therapeutics emphasizes its commitment to developing treatments that significantly improve the lives of patients with CNS disorders. The data presented at the ASCP Annual Meeting underscores this mission, showcasing the potential of existing and emerging therapies to address unmet clinical needs.
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