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Axsome Therapeutics has announced that its new drug, AXS-07, has reached its end in Phase III migraine trials.
Compared to placebos, this oral, multi-mechanism study drug reached two common major research endpoints and significantly improved migraines and the most annoying symptoms.
The MOMENTUMIII phase trial also reached a critical secondary endpoint, statistically superior to its active referencer Rizatriptan in terms of continued pain from migraines.
In the trial, 19.9 percent of patients who had no the most severe symptoms of pain within two hours of taking the drug had pain freedom, while 6.7 percent had pain freedom, while 36.9 percent and 24.4 percent had no pain.
Positive results support applications for AXS-07 for acute treatment of migraines (NDA).
Richard Lipton, professor and deputy director and director of neurology, said that given that rizatriptan is one of the most effective tuptans, "the findings are impressive for patients with refractic migraines in the study." "Montefior Headache Center, Albert Einstein College of Medicine.
He continued: "Many patients do not respond well to current acute migraine treatment, increasing their risk of headache-related disabilities and developing chronic migraines, which are associated with increased medical costs. The results of this study suggest that AXS-07 may provide important treatment options for people with difficulty treating migraines. In
, the AXS-07 is safe and well-to-bear in tests, in addition to its efficacy. The most common adverse events reported were nausea, dizziness and drowsiness, with no occurrence higher than placebo or above 3%.
Axsome's share increased by more than 80 percent last month after the Phase III study of the experimental drug AXS-05 in adults with moderate to severe depression reached its primary endpoint. (cyy123.com)