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Axsome Therapeutics Reports Results of AXS-07 in MOMENTUM P-III Migraine Trial in Patients with History of Inadequate Response

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Axsome Therapeutics Reports Results of AXS-07 in MOMENTUM P-III Migraine Trial in Patients with History of Inadequate Response

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  • The P-III MOMENTUM study involves assessing of AXS-07 vs PBO and rizatriptan in 1-594 patients in ratio (2:2:2:1) to treat a single migraine attack of moderate or severe intensity. Additionally- the trial was conducted pursuant to SPA with the FDA
  • MOMENTUM P-III study results: met its co-primary endpoints with achievement in pain freedom (19.9% versus 6.7%)- absence of most bothersome symptom (36.9% vs 24.4%)- - pain relief @2 to 24 & @2 to 48 hrs (53.3% vs 33.5%- 43.9%) & (46.5% vs 31.1%- 36.5%)- rescue medication (23.0% vs 43.5%- 34.7%)- experience pain post @1.5hrs (60.5% vs 60.5% and 48.3%)- pain freedom from 2 to 24 hrs. (16.1% vs 11.2%- and 8.8%)
  • AXS-07 oral- investigational medicine with dual of action under development for the acute treatment of migraine with expected NDA submission in H2’20 for acute treatment of migraine

Click here to read full press release/ article | Ref: Globe Newswire | Image: Signbox


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