Axsome Therapeutics Inc reported third-quarter financial results and business updates, noting a continued increase in prescriptions for Sunosi (solriamfetol), used to reduce excessive daytime sleepiness in adults with narcolepsy or sleep apnea, and clinical trial progress.
Third-quarter 2023 US Sunosi total prescriptions increased by 16% versus the third quarter of 2022 and sequentially by 5% versus the second 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.
Axsome is advancing a portfolio of differentiated, patent-protected, product candidates, including AXS-12 (reboxetine), 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.
Axsome is conducting the SYMPHONY study, a phase 3 randomized, multicenter, double-blind, placebo-controlled, parallel-group trial of AXS-12 in the treatment of narcolepsy. The company is on track to complete enrollment in the SYMPHONY trial in the fourth quarter of 2023, with the announcement of topline results anticipated in the first quarter of 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 and is on track to initiate a phase 3 trial in patients with excessive sleepiness associated with shift work disorder in the first quarter of 2024.
An estimated one-third of Americans perform shift work, of whom 10-43% are diagnosed with shift work disorder. Treatment options are limited with only two products currently approved for the treatment of excessive sleepiness associated with the disorder.