Axsome’s Sunosi Shows Mixed Results in MDD Trial, But Promising Efficacy for Patients with Excessive Daytime Sleepiness” ###
Trial Overview:
Axsome conducted the Phase 3 PARADIGM trial to evaluate Sunosi (solriamfetol) in patients with Major Depressive Disorder (MDD), including those with and without excessive daytime sleepiness (EDS).
Outcomes:
While the trial did not meet the primary endpoint of statistically significant improvement in depression symptoms for the overall population, patients with severe EDS showed clinically meaningful improvements.
EDS Subgroup Findings:
In patients with severe EDS (Epworth Sleepiness Scale score ≥16), solriamfetol at 300 mg yielded greater improvements on metrics such as MADRS total score, remission rates, and patient-reported outcomes compared to placebo.
Mechanism of Action:
Solriamfetol acts as a dopamine and norepinephrine reuptake inhibitor, with additional activity as a TAAR1 and 5-HT1A receptor agonist, targeting wakefulness and mood symptoms.
Unmet Need:
Approximately 50% of MDD patients experience EDS, and there are no approved therapies addressing this combined condition.
Next Steps:
Axsome plans to initiate a targeted Phase 3 trial exclusively for MDD patients with EDS in 2025 to further investigate efficacy and clinical significance.
Safety Profile:
The drug showed a favorable safety and tolerability profile consistent with its known effects in treating EDS linked to narcolepsy and sleep apnea.
Market Potential:
If successful, Sunosi could address significant unmet needs in MDD with EDS and expand its market reach beyond its current indications.