Axsome AXS-12 gets FDA breakthrough therapy designation for narcolepsy

Axsome Therapeutics

The FDA granted Axsome Therapeutics’ (NASDAQ:AXSM) AXS-12 breakthrough therapy designation for the treatment of cataplexy in patients with narcolepsy.

Narcolepsy is a neurological condition characterized by excessive daytime sleepiness and cataplexy, a sudden loss of muscle tone triggered by strong emotions. 

AXS-12 is an oral norepinephrine reuptake inhibitor designed to modulate noradrenergic activity to promote wakefulness, maintain muscle tone and enhance cognition. 

“This FDA breakthrough therapy designation for AXS-12 for cataplexy in narcolepsy highlights its potential, should it be successfully developed, to provide meaningful benefit and substantial improvement over currently available treatment options for patients living with this debilitating condition,” Dr. Herriot Tabuteau, CEO of Axsome, said in a statement. 

AXS-12 received FDA orphan drug designation for the treatment of narcolepsy in October 2018.

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