Key takeaways:

• The FDA accepted the new drug application for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy.
• A Prescription Drug User Fee Act (PDUFA) target action date is set for May 1, 2027.
• The FDA indicated it does not currently plan to hold an advisory committee meeting to discuss the application.
• AXS-12 previously received Orphan Drug Designation from the FDA for the treatment of narcolepsy.

The US Food and Drug Administration (FDA) has accepted for filing a New Drug Application from Axsome Therapeutics Inc for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy.

The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. Additionally, the agency indicated that it does not currently plan to hold an advisory committee meeting to discuss the application.

AXS-12 is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. The investigational drug is thought to modulate noradrenergic activity to maintain muscle tone during wakefulness, as well as noradrenergic and cortical dopaminergic signaling to promote wakefulness and cognitive function. AXS-12 has been granted FDA Orphan Drug Designation for the treatment of narcolepsy but is not currently approved by the FDA.

Cataplexy involves a sudden reduction or loss of muscle tone while a patient is awake, typically triggered by strong emotions such as laughter, fear, anger, stress, or excitement.