Novel Narcolepsy Treatment Gets Orphan Drug Designation

AXS-12 is a highly selective norepinephrine reuptake inhibitor
AXS-12 is a highly selective norepinephrine reuptake inhibitor

The Food and Drug Administration (FDA) has granted Orphan Drug designation to AXS-12 (reboxetine; Axsome Therapeutics), an oral medicine in development for the treatment of the symptoms of narcolepsy

AXS-12 is a highly selective norepinephrine reuptake inhibitor. The Company stated that they plan to begin a Phase 2 trial of AXS-12 before the end of 2018, with results anticipated for the first half of 2019. 

"The designation is an important regulatory milestone in the development of AXS-12 for this debilitating condition," said Herriot Tabuteau, MD, CEO of Axsome. "We look forward to starting our planned Phase 2 trial of AXS-12 in patients with narcolepsy this quarter." 

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According to the National Institute of Neurological Disorders and Stroke, the estimated number of people in the US with narcolepsy ranges from 135,000 to 200,000. 

For more information visit Axsome.com.