In its second-quarter business highlights, Axsome Therapeutics Inc provided updates on a new potential indication for solriamfetol for shift work disorder, announced progress for its narcolepsy drug candidate, and revealed positive results from the Q2 relaunch of Sunosi.

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. Axsome recently received positive pre-IND meeting feedback from the US Food and Drug Administration (FDA) on the development of solriamfetol for the treatment of excessive sleepiness associated with shift work disorder, a potentially new indication for solriamfetol. 

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 shift work disorder. Based on the FDA’s feedback, the company is preparing to initiate a phase 3 trial of solriamfetol in patients with excessive sleepiness associated with shift work disorder in the first quarter of 2024.

Additionally, Axsome’s AXS-12 (reboxetine), a novel, oral, potent, investigational highly selective norepinephrine reuptake inhibitor for the treatment of narcolepsy, continues to advance through the development pipeline. 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 anticipates completion of the SYMPHONY trial in the fourth quarter of 2023.

According to the company, the relaunch of Sunosi (solriamfetol), used to reduce excessive daytime sleepiness in adults with narcolepsy or sleep apnea, is well underway, and positive results are being seen from these efforts. Second-quarter US Sunosi total prescriptions increased by 15% versus the second quarter of 2022 and sequentially by 8% versus the first quarter of 2023.

Sunosi maintains broad payer coverage in the commercial channel with 95% of lives covered. Currently, 83% of lives across all channels are covered, according to a release from Axsome.

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