vorvida is filed at FDA by Orexo AB to treat alcohol use disorder .

Orexo AB (publ), announces it has submitted an application to the 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 2020, Orexo intends to initiate the commercialization in the second half of 2020. vorvida has already been launched successfully in Germany and Switzerland in 2019 by GAIA AG (GAIA). This news follows the November 2019 announcement of Orexo’s acquisition of the US commercialization rights of the therapy from GAIA. vorvida (Orexo project no. OXD02) is a digital therapeutic designed to offer patients quality psychotherapy intervention based on cognitive behavioral therapy and motivational interviewing.It was developed by GAIA and is based on its proprietary artificial intelligence (AI)-expert system, broca. vorvida is scientifically proven to reduce troublesome drinking patterns in adults with harmful alcohol consumption. In a randomized controlled trial, conducted in Germany, involving 608 adults with problematic alcohol intake, researchers found that participants in the intervention group using vorvida, saw a significant reduction in their daily alcohol consumption over three and six months, with significant effect sizes. Additionally, in comparison to the control group, vorvida users reported fewer days of binge drinking and drunkenness while stating high acceptance and utility rates of vorvida at the same time.