5 August 2020 - FDA Orphan Drug Designation previously granted to Axsome for AXS-12 in narcolepsy.
Axsome Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for AXS-12 for the treatment of cataplexy in patients with narcolepsy.
AXS-12 is a novel, oral, highly selective and potent norepinephrine re-uptake inhibitor.