During its fourth-quarter and full-year 2022 earnings call today, Axsome Therapeutics provided business updates on Sunosi (solriamfetol), used to reduce excessive daytime sleepiness in adults with narcolepsy or sleep apnea, and AXS-12 (reboxetine), a narcolepsy drug candidate in clinical trials. 

Axsome, which began selling Sunosi in the US in May 2022 after acquiring the drug from Jazz Pharmaceuticals, noted it closed the ex-US acquisition of Sunosi in the fourth quarter. It began selling it in certain international markets in November 2022.

Subsequently this month, Axsome licensed the marketing rights for Sunosi in Europe and certain countries in the Middle East and North Africa to Pharmanovia. In consideration, Axsome received an upfront payment of $66 million, with potential milestones up to $101 million. Axsome will receive a royalty percentage in the mid-20s on net sales in the licensed territory. Pharmanovia will assume responsibility for all local clinical and regulatory activities and requirements, including studies in pediatric patients with narcolepsy.

Fourth-quarter US Sunosi total prescriptions increased by 11% versus the fourth quarter of 2021 and by 1% versus the third quarter of 2022. Full-year Sunosi total prescriptions grew 21% in 2022 over 2021. 

Axsome also has several drugs, including AXS-12, in its development pipeline. AXS-12 is Axsome’s novel, oral, potent, investigational highly selective norepinephrine reuptake inhibitor for treating narcolepsy. AXS-12 has been granted US Food and Drug Administration Orphan Drug designation.

Axsome is conducting the SYMPHONY (Study Evaluating a Mechanistic Approach to Treating Narcolepsy) study, a phase 3 randomized, multicenter, double-blind, placebo-controlled, parallel-group trial of AXS-12. Enrollment in the trial is progressing.

Axsome says in a press release that topline results from the study are anticipated in the first half of this year.

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