Axsome Therapeutics Initiates Phase 2 Trial of AXS-12 in Narcolepsy
Topline results anticipated in 2Q 2019
“The initiation of the CONCERT trial of AXS-12 for the treatment of narcolepsy reflects Axsome’s advancing pipeline of differentiated CNS product candidates, and our continued commitment to developing novel medicines to improve the lives of patients living with serious and difficult-to-treat CNS disorders,” said
“Narcolepsy is debilitating for the nearly 200,000 individuals living with this condition in the U.S. Unfortunately, treatment options for these patients are limited,” said Cedric O’Gorman, MD, Senior Vice President of Clinical Development and Medical Affairs of Axsome. “AXS-12 has the potential to address the key symptoms of this disorder and may not share the limitations of currently approved agents. We look forward to evaluating the potential of AXS-12 in the CONCERT trial, with the goal of providing a more effective treatment for narcolepsy.”
About the CONCERT Trial
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. The study will enroll approximately 20 patients, all of whom will be treated with AXS-12 for three weeks, and with placebo for three weeks. Eligible patients will be randomized to receive either AXS-12 followed by placebo, or placebo followed by AXS-12. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.
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. Narcolepsy afflicts an estimated 185,000 individuals in the U.S. 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 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. Depression is reported in up to 57% of patients.
AXS-12 (reboxetine) is a novel, oral, investigational medicine in development for the treatment of the symptoms of narcolepsy. AXS-12 is a highly selective and potent norepinephrine reuptake inhibitor. AXS-12 is an investigational drug product not approved by the
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Source: Axsome Therapeutics, Inc.