![]() In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. The Company may occasionally disseminate material, nonpublic information on the company website.Ĭertain matters discussed in this press release are “forward-looking statements”. For more information, please visit the Company’s website at. At Axsome, we are intensely committed to developing products that meaningfully improve the lives of patients and provide additional therapeutic options for physicians. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options. ![]() ![]() AXS-12 is an investigational drug product not approved by the FDA.Īxsome Therapeutics, Inc. Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 modulates noradrenergic activity to promote wakefulness, maintain muscle tone and enhance cognition. Narcolepsy interferes with cognitive, psychological, and social functioning, increases the risk of work- and driving-related accidents, and is associated with a 1.5-fold higher mortality rate.ĪXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor under development for the treatment of narcolepsy. Cataplexy is seen in an estimated 70% of narcolepsy patients and is a sudden reduction or loss of muscle tone while a patient is awake, typically triggered by strong emotions such as laughter, fear, anger, stress, or excitement. Narcolepsy afflicts an estimated 185,000 individuals in the U.S. Narcolepsy is a serious and debilitating neurological condition that causes dysregulation of the sleep-wake cycle and is characterized clinically by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep. Other symptoms of narcolepsy as well as safety will be assessed throughout the study. The primary endpoint will be the frequency of cataplexy attacks. Approximately 90 patients will be randomized in a 1:1 ratio to treatment with AXS-12 or placebo for 5 weeks. ![]() SYMPHONY (Study Evaluating a Mechanistic Approach to Treating Narcolepsy) is a Phase 3, randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of AXS-12 in patients with narcolepsy. Food and Drug Administration for the treatment of narcolepsy. If successfully developed, AXS-12 may address multiple symptoms of this debilitating condition.”ĪXS-12 has been granted Orphan Drug Designation by the U.S. “Narcolepsy impairs almost every aspect of a patient’s life including cognitive, psychological, social, and emotional functioning. “The advancement of AXS-12 into Phase 3 testing for narcolepsy demonstrates Axsome’s commitment to developing important new medicines for patients living with serious CNS conditions,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. Topline results from the SYMPHONY trial are anticipated in the first half of 2023. ![]() AXS-12 is a novel, oral, potent, and highly selective norepinephrine reuptake inhibitor. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, enrolled the first patient in SYMPHONY (Study Evaluating a Mechanistic Approach to Treating Narcolepsy), a Phase 3, randomized, double-blind, placebo-controlled trial of AXS-12 in patients with narcolepsy. 16, 2021 (GLOBE NEWSWIRE) - Axsome Therapeutics, Inc. ![]()
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