This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Eligible subjects must have a diagnosis of narcolepsy per the International Classification of Sleep Disorders (ICSD-3), and exhibit symptoms of both cataplexy and EDS. Subjects meeting the entry criteria will be randomized in a 1:1 ratio to receive either AXS-12 or placebo for five weeks.

Inclusion Criteria:

• Male or female subjects between 15 and 75 years of age, inclusive
• Primary diagnosis of narcolepsy with cataplexy
• Willing and able to comply with the study requirements

Exclusion Criteria:

• Other clinically significant conditions potentially causing EDS
• Clinically significant psychiatric disorders