(Reuters) -The U.S. Food and Drug Administration has approved Axsome Therapeutics’ migraine treatment, the company said on Thursday. The oral drug, branded Symbravo, was approved for the acute treatment of the condition characterized by recurrent attacks of moderate to severe throbbing and pulsating pain on one side of the head. The prescribing information carries a […]
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US FDA approves Axsome Therapeutics’ migraine drug
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(Reuters) -The U.S. Food and Drug Administration has approved Axsome Therapeutics’ migraine treatment, the company said on Thursday.
The oral drug, branded Symbravo, was approved for the acute treatment of the condition characterized by recurrent attacks of moderate to severe throbbing and pulsating pain on one side of the head.
The prescribing information carries a boxed warning, the FDA’s most prominent, for the risk of serious cardiovascular and gastrointestinal side effects, including heart attack and stroke, as well as bleeding and ulceration of the stomach or intestines.
Symbravo is a combination of two compounds, meloxicam and rizatriptan, designed to provide rapid and sustained relief to acute migraine pain, Axsome said.
The company expects the drug to be commercially available in the U.S. in about four months.
TD Cowen analysts estimated peak U.S. sales of $200 million.
The approval was based on two late-stage trials that showed the drug led to significant elimination of migraine pain compared with a placebo.
The FDA had declined to approve the drug in 2022 over unresolved issues of its quality control processes.
(Reporting by Mariam Sunny in Bengaluru; Editing by Maju Samuel and Sriraj Kalluvila)