Sage’s depression drug meets main goal in late-stage study -Breaking
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© Reuters. FILE PHOTO – A test tube can be seen facing the Biogen logo. This illustration was taken December 1, 2021. REUTERS/Dado Ruvic/Illustration/File Photo(Reuters). Sage Therapeutics Inc reported Wednesday that its drug and an antidepressant combined helped to improve depression symptoms in a study of three days. The drug developer will now be able to submit data for U.S. FDA approval for this year.
Partner Biogen Inc (NASDAQ) stated that zuranolone met secondary study goals of showing improvement in symptoms for a period of two weeks.
The study involved 440 people with major depression. Zuranolone was combined with antidepressants to reduce symptoms such as sadness and anxiety. This resulted in a lower incidence of the disorder than a placebo.
Major depressive disorder (MDD), which is a severe mood disorder that can cause depressive symptoms, affects approximately 16 million adults in America each year.
Antidepressants are the most common treatment. It can take as long as six weeks for these drugs to kick in. Patients will need to keep taking them until they do.
Sage Therapeutics chief innovation officer Jeff Jonas stated, “What this study did, we believe is just substantiated that zuranolone might be a unique option for patients.”
“We think that people deserve the option to be better within days than weeks.
Sage will begin submitting data to the U.S. for approval on a continuous basis in early 2012 and hopes to finish the application by mid-2012.
The companies stated that zuranolone was generally tolerated without any new safety concerns in the study.
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