Barriers to Axsome AXS-07 migraine treatment beyond FDA approval, its
Central nervous system (CNS) specialist Axsome Therapeutics (Nasdaq: AXSM) expects to receive a full response letter (CRL) from the FDA due to chemistry, manufacturing and control (CMS) issues recently revealed during of the FDA’s review of its New Drug Application for AXS-07 (rizatriptan and meloxicam), for the acute treatment of migraine headaches.
According to the report by industry analyst firm GlobalData, “Migraine Drug…
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