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Axsome
NEWS

Axsome Therapeutics Reports the US FDA’s sNDA Acceptance with Priority Review of AXS-05 for the Treatment of Alzheimer’s Disease Agitation

Shots: The US FDA has accepted sNDA & granted priority review to AXS-05 (dextromethorphan HBr and bupropion HCl) to treat Alzheimer’s disease agitation (PDUFA: April 30, 2026) The sNDA reflects AXS-05’s clinical development program in Alzheimer’s disease agitation, which included four randomized, double-blind P-III trials and a long-term safety study AXS-05 is an oral investigational…
January 1, 2026

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Axsome
NEWS

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…
April 2, 2025

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Axsome
NEWS

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%…
January 31, 2025

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