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.”
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.