About 45,000 prescriptions were written for sunosi (solriamfetol), a dual-acting dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adult patients with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea in the United States, in the second quarter (Q2) of 2024, according to Axsome Therapeutics Inc.
This represents an 8% increase in sunosi prescriptions versus the first quarter of 2024 and 15% growth versus Q2 of 2023. “By comparison, the wake-promoting agent market grew 4% sequentially and declined 1% compared to the second quarter of 2023,” said Ari Maizel, executive vice president, head of commercial at Axsome, the company’s Q2 conference call.
“Of note, sunosi had strong performance with new patient prescriptions in Q2. With more than 4,200 new patients initiating sunosi treatment during the quarter,” Maizel said. “In addition, approximately 400 new writers were activated in Q2, as sunosi continues to grow adoption across the universe of sleep specialists in the United States.”
Sunosi net product revenue was $22.1 million for the second quarter of 2024, consisting of $21.5 million in net product sales and $0.6 million in royalty revenue associated with sales in out-licensed territories, representing 16% year-over-year growth. Sunosi net product revenue for the comparable period in 2023 was $19.1 million, consisting of $18.4 million in net product sales and $0.7 million in royalty revenue.
Sunosi’s payor coverage was stable during the quarter, with 95% of lives covered.
Axsome Clinical Trials
Solriamfetol Trials
Axsome is pursuing potential additional indications for solriamfetol. It is being developed for the treatment of attention deficit hyperactivity disorder, major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder.
Axsome has initiated the SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) study, a phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol for the treatment of shift work disorder in adults. The company anticipates topline results in 2026.
AXS-12 Trials
AXS-12 (reboxetine) is Axsome’s novel, oral, potent, investigational highly selective 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.
Axsome is conducting a phase 3 open-label safety extension trial of AXS-12 with topline results anticipated in the fourth quarter of 2024. AXS-12 has previously met the primary endpoints and demonstrated positive and statistically significant results in the completed SYMPHONY phase 3 and CONCERT phase 2 trials in patients with narcolepsy.
Leave a Reply