AXS-12 Updates
Based on the results of three controlled phase 2 and 3 efficacy trials and a long-term safety trial of AXS-12 in patients with narcolepsy with cataplexy, Axsome Therapeutics Inc expects to submit a new drug application for AXS-12 (reboxetine) for the treatment of cataplexy in patients with narcolepsy to the US Food and Drug Administration (FDA) in the second half of 2025.
Axsome AXS-12, which has been granted FDA Orphan Drug designation for narcolepsy, is a novel, oral, investigational, highly selective, and potent norepinephrine reuptake inhibitor and cortical dopamine modulator. AXS-12 demonstrated statistically significant efficacy compared to placebo in all three efficacy trials (CONCERT, SYMPHONY, and ENCORE).
Solriamfetol Updates
Axsome also recently shared updates on solriamfetol, a dopamine and norepinephrine reuptake inhibitor, TAAR1 agonist, and 5-HT1A agonist that is FDA-approved for improving wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
Axsome is developing solriamfetol for the treatment of attention deficit hyperactivity disorder, major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder.
- Attention Deficit Hyperactivity Disorder (ADHD): Axsome is conducting the FOCUS study, a phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in ADHD in adults. The company is on track to report topline results from the FOCUS phase 3 trial in the first quarter of 2025.
- Major Depressive Disorder: Axsome is conducting the PARADIGM study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in major depressive disorder. The study will examine the effect of solriamfetol in people with major depressive disorder with and without excessive daytime sleepiness. The company is on track to report topline results from the PARADIGM Phase 3 trial in the first quarter of 2025.
- Binge Eating Disorder: Axsome is conducting the ENGAGE study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in binge eating disorder. Based on current enrollment trends, the company anticipates topline results from the ENGAGE phase 3 trial in 2026.
- 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 SUSTAIN phase 3 trial in 2026.
Sunosi Updates
According to Axsome, about 49,000 prescriptions were written for Sunosi (the brand name of solriamfetol for the indication of improving wakefulness in people narcolepsy or obstructive sleep apnea) in the United States in the fourth quarter of 2024, representing an increase of 16% compared to the same period in 2023, and an increase of 4% compared to the third 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.
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