Axsome Therapeutics Reports Topline Data of P-III (PARADIGM) Trial of Solriamfetol for Major Depressive Disorder (MDD) regardless of Excessive Daytime Sleepiness (EDS)

Shots:Axsome reported topline data of PoC P-III (PARADIGM) trial assessing solriamfetol (300mg) vs PBO in MDD pts with severe EDS (ESS ≥16; n=51) & those without severe EDS (n=295)Trial showed no significant MADRS total score change (1EP) in the overall population. However, EDS pts saw depressive symptom improvements across MADRS total score, MADRS…

ByRidhi RastogiApril 2, 2025

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Axsome Therapeutics Reports P-III (FOCUS) Trial Data of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD)

Shots:Axsome Therapeutics has reported P-III (FOCUS) trial data assessing solriamfetol (150 or 300mg, QD) vs PBO for 6wks. to treat of ADHD adults (n=516) in the USTrial met its 1EP, with 150mg showing greater AISRS score reductions vs PBO at Wk. 6 (17.7 vs 14.3 mean point decrease); improvements began at Wk. 1,…

ByRidhi RastogiMarch 26, 2025

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Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

Shots:The US FDA has approved Symbravo for acute treatment of migraine with/without aura in adults based on P-III (MOMENTUM), P-III (INTERCEPT) & P-III (MOVEMENT) trial; commercially available in ~4mons. MOMENTUM trial assessed Symbravo (single dose) vs PBO/meloxicam/rizatriptan, showing greater pain & symptoms freedom (photophobia, phonophobia & nausea) at 2hrs., sustained through 24-48hrs., 77%…

ByDipanshu DixitJanuary 31, 2025

Axsome Therapeutics Reports Topline Data of P-III (PARADIGM) Trial of Solriamfetol for Major Depressive Disorder (MDD) regardless of Excessive Daytime Sleepiness (EDS)

Axsome Therapeutics Reports P-III (FOCUS) Trial Data of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD)

Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

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