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Biologics company Axsome Therapeutics announced today that the AXS-07 Long-Term Open Phase III Trial (MOVEMENT Study) has yielded positive results.
trial, the AXS-07 quickly and persistently relieves migraines and related symptoms.
AXS-07 is well-resistant in long-term treatment and its safety is consistent with previously reported controlled trials.
Axsome is still expected to submit an NDA on AXS-07 to the FDA in the first quarter of 2021.
, chief executive of Axsome, said: "THE MOVEMENT study confirms that the AXS-07 is powerful and demonstrates good long-term safety."
in the MOVEMENT trial, a total of 706 patients were admitted to the group.
at the end of the study, 515 patients were treated for at least six months and 155 patients were treated for at least 12 months.
results showed that AXS-07 provided lasting relief from migraines, with 24 percent of patients not using first aid drugs within 24 hours and 83 percent not using first aid drugs within 48 hours.
60 per cent (range: 59-62 per cent) and 59 per cent (58-60 per cent), respectively, for 2 to 24 hours and 2 to 48 hours.
