Axsome Therapeutics Inc, manufacturer of Sunosi for excessive daytime sleepiness in narcolepsy and sleep apnea, prepares to read out a phase 3 trial for narcolepsy drug candidate AXS-12 and initiate a new pivotal trial for solriamfetol in shift work disorder this quarter.

The anticipated milestones were announced alongside business highlights for the fourth quarter and full year of 2023.

AXS-12 in the development pipeline:

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 US Food and Drug Administration Orphan Drug designation for the treatment of narcolepsy.

  • Narcolepsy: Enrollment in the SYMPHONY study, a phase 3 randomized, multicenter, double-blind, placebo-controlled, parallel-group trial of AXS-12 in the treatment of narcolepsy has been completed. The Company is on track to announce topline results for SYMPHONY this quarter.

Solriamfetol in the development pipeline:

Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor and TAAR1 agonist in development for the treatment of excessive sleepiness associated with shift work disorder.

  • Shift Work Disorder: The Company plans to initiate a Phase 3 trial of solriamfetol for the treatment of excessive sleepiness (ES) associated with SWD in the first quarter of 2024.

Fourth-quarter 2023 and full-year commercial highlights for Sunosi:

  • Approximately 42,000 prescriptions were written for Sunosi in the United States in the fourth quarter of 2023, representing an 18% increase versus the fourth quarter of 2022 and a 2% sequential increase versus the third quarter of 2023. 
  • Sunosi maintains broad payer coverage in the commercial channel with 95% of lives covered. Currently 83% of total lives across all channels are covered.

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