Summary: Axsome Therapeutics reported growth in its sleep medicine portfolio for the third quarter of 2024, driven by increased uptake of its wake-promoting drug, Sunosi. The company also highlighted progress in its late-stage clinical trials for AXS-12 (targeting narcolepsy) and solriamfetol (targeting shift work disorder, ADHD, and other conditions). Axsome plans to release key trial results by the end of 2024 and into 2025.
Key Takeaways:
- Increased Sunosi Sales: Axsome reported $24.4 million in revenue from Sunosi for Q3 2024, with a 21% year-over-year increase in net sales and a 15% rise in prescriptions compared to Q3 2023.
- Advancement in Clinical Trials for Narcolepsy: Axsome is progressing with its phase 3 ENCORE trial for AXS-12 in narcolepsy, with results expected in Q4 2024.
- Trial for Shift Work Disorder: Axsome is progressing with its phase 3 SUSTAIN study for solriamfetol in shift work disorder, with results expected in 2026.
Axsome Therapeutics reported continued growth in its sleep medicine portfolio for the third quarter of 2024, driven by increased uptake of its wake-promoting drug Sunosi and advancements in its late-stage pipeline, including AXS-12 and solriamfetol.
“In the third quarter, we continued our strong commercial performance and advanced our innovative, industry-leading, late-stage development pipeline towards important near-term milestones,” says Herriot Tabuteau, MD, chief executive officer, in a release.
Sunosi net product revenue was $24.4 million for the third quarter of 2024, representing 21% year-over-year growth, which consisted of $23.4 million in net product sales and $1 million in royalty revenue associated with sales in out-licensed territories. Sunosi net product revenue for the comparable period in 2023 was $20.1 million, consisting of $19.4 million in net product sales and $0.7 million in royalty revenue.
Approximately 47,000 prescriptions were written for Sunosi in the US in the third quarter of 2024, representing an increase of 15% compared to the same period in 2023, and an increase of 5% compared to the second quarter of 2024.
Payer coverage for Sunosi across all channels is at approximately 83% of all covered lives. The proportion of lives covered for Sunosi in the commercial and government channels are approximately 95% and 60%, respectively.
Development Pipeline
Axsome is advancing a neuroscience pipeline encompassing five innovative, late-stage, patent-protected product candidates for nine psychiatric and neurological conditions, including two being developed for narcolepsy and excessive sleepiness associated with shift work disorder.
Updates on the sleep medicine drug candidates are as follows:
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral, potent, highly selective investigational norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for narcolepsy.
- Narcolepsy: Axsome is conducting the ENCORE study, a two-period phase 3 trial evaluating the long-term efficacy and safety of AXS-12 in narcolepsy, consisting of a 24-week open-label period followed by a 3-week, double-blind, placebo-controlled, randomized withdrawal period. Enrollment in the ENCORE trial is complete, and Axsome remains on track to report topline results from the trial in the fourth quarter of 2024.
Solriamfetol
Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor, TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder, major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder.
- Shift Work Disorder: Axsome is conducting the SUSTAIN study, a phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in shift work disorder in adults. The company anticipates topline results from the trial in 2026.
Scientific Presentations and Corporate Update
In September, Axsome presented multiple data analyses at Sleep Europe 2024, including results from the SYMPHONY phase 3 trial of AXS-12 in narcolepsy and findings from the CRESCENDO patient survey underscoring the unmet needs of patients with type 1 narcolepsy.
In August, Axsome announced that the patent litigation with Sandoz Inc (Sandoz) related to Sunosi (solriamfetol) was dismissed following Sandoz’s withdrawal of its ANDA for a generic equivalent of Sunosi. As a result, the litigation with Sandoz has been dismissed without prejudice.
“Our growth as an organization positions us well to potentially deliver multiple innovative new medicines to the millions of individuals living with central nervous system disorders in the US Importantly, we have the resources in hand to execute our operating plans and create substantial value for shareholders,” says Tabuteau in a release.
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