Axsome Therapeutics Inc, a clinical-stage biopharmaceutical company developing therapies for the management of central nervous system (CNS) disorders, has initiated the CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) study, a Phase 2, randomized, controlled trial of AXS-12 (reboxetine) in narcolepsy. AXS-12 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of narcolepsy. Topline results from the CONCERT trial are expected in the second quarter of 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,” says Herriot Tabuteau, MD, CEO of Axsome, in a release. “The CONCERT trial utilizes an efficient crossover design to improve signal detection and speed trial conduct. We look forward to topline results from this study in the second quarter of this year.”

Cedric O’Gorman, MD, senior vice president of clinical development and medical affairs of Axsome, says, “Narcolepsy is debilitating for the nearly 200,000 individuals living with this condition in the US. Unfortunately, treatment options for these patients are limited. 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.”