Axsome Therapeutics Inc, manufacturer of Sunosi for excessive daytime sleepiness in narcolepsy and sleep apnea, disclosed preliminary revenue for 2023 and detailed anticipated milestones for investigational drugs for narcolepsy and excessive daytime sleepiness associated with shift work disorder.

For the full year ended Dec 31, 2023, Axsome reported prescriptions for Sunosi totaling more than 139,000. Sunosi’s net product revenue is expected to be $22 million and $74 million for the fourth quarter and full year of 2023, respectively.

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. Sunosi received US Food and Drug Administration approval on March 20, 2019, and was designated a Schedule IV medicine by the US Drug Enforcement Agency on June 17, 2019. Sunosi has Orphan Drug designation for narcolepsy in the United States. 

Additionally, Axsome anticipates multiple clinical and regulatory milestones in 2024 for investigational drugs targeting other sleep disorders. These include topline results of the SYMPHONY trial in narcolepsy and initiation of a phase 3 trial of solriamfetol in excessive sleepiness associated with shift work disorder.

2024 Development Pipeline Anticipated Milestones

  • Clinical Trial Topline Results:
    • Phase 3 SYMPHONY trial of AXS-12 in narcolepsy (1Q 2024)
    •  AXS-12 (reboxetine) is Axsome’s novel oral, potent, investigational highly selective norepinephrine reuptake inhibitor for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for the treatment of narcolepsy.
  • Clinical Trial Initiations:
    • Phase 3 trial of solriamfetol in shift work disorder (SWD) (1Q 2024)
    • Axsome previously received positive pre-IND meeting feedback from the US Food and Drug Administration on the development of solriamfetol for the treatment of excessive sleepiness associated with shift work disorder, a potentially new indication for solriamfetol.

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