Orexo has submitted an application to the Food and Drug Administration (FDA) for Vorvida® (OXD02), a digital therapy, to enable commercialization in the US for the treatment of bothersome or harmful alcohol consumption including diagnosed alcohol use disorder.
In November 2019, Orexo acquired US commercialization rights of Vorvida from GAIA. The fully automated digital therapy uses GAIA’s artificial intelligence (broca®) to provide users with psychotherapy intervention based on cognitive behavioral therapy and motivational interviewing.
The digital therapy was evaluated in a randomized controlled trial that included 608 adult patients with problematic alcohol intake. Findings showed significant reductions in daily alcohol consumption, binge drinking and intoxication over 3 and 6 months with significant effect sizes. Additionally, high satisfaction rates were observed among Vorvida-treated patients.
The Company expects to initiate the commercialization of Vorvida in the second half of 2020 subject to FDA approval.
“Access to Vorvida will enable patients to treat heavy alcohol use in their homes, when they need it the most,” said Nikolaj Sørensen, CEO and President of Orexo AB. “This ease of use combined with the strong clinical evidence, suggests Vorvida could present an important treatment option for patients.”
For more information visit orexo.com.