Orexo submits application for vorvida® to the FDA to enable commercialization in the US
· vorvida® clearance from FDA anticipated Q2 2020 · expects to launch its first digital therapy in the US for heavy alcohol use in H2 2020 Uppsala, Sweden – March 6, 2020. Orexo AB (publ), today announces it has submitted an application to the US Food and Drug Administration (FDA) for vorvida® to enable commercialization in the US. vorvida®, is a digital therapy with clinically proven efficacy for the treatment of bothersome or harmful alcohol consumption including diagnosed alcohol use disorder (AUD). Subject to hearing from the FDA, which is expected during the second quarter of