Short facts

 

API

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Technology

Digital therapeutics

Indication

Heavy alcohol misuse, incl. alcohol use disorder

Development phase

Registration with FDA in the US

Expected filing with FDA

Was filed with FDA in beginning of March 2020. Launch is expected to take place in H2 2020.

In-house or partnership

Partnership with GAIA AG

The Concept/Product

OXD02/vorvida® is a fully automated digital therapy developed by Orexo´s partner 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 AUD.

AUD is a major health crisis affecting approximately 16.6 million people in the United States.1 Each year, more than 88,000 people die from alcohol-related causes,2 making it the third leading preventable cause of death in the country. Alcohol misuse costs the United States about USD 249 billion per year.3

Orexo owns the exclusive commercial rights for Vorvida® in the US.

Clinical Data

In a randomized controlled trial involving 608 adults with problematic alcohol intake, researchers found that participants in the intervention group with vorvida® significantly reduced their daily alcohol consumption over three and six months, with significant effect sizes.4 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.

Substance Abuse and Mental Health Services Administration (SAMHSA).

Sacks, J.J.; Gonzales, K.R.; Bouchery, E.E.; Tomedi, L.E.; and Brewer, R.D. 2010 National and state costs of excessive alcohol consumption. American Journal of Preventive Medicine49(5):e73–e79, 2015.

Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2017 National Survey on Drug Use and Health: Detailed Tables. Table 5.5A—Alcohol Use Disorder in Past Year Among Persons Aged 12 or Older, by Age Group and Demographic Characteristics: Numbers in Thousands, 2016 and 2017. https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017. htm.

4 Jördis M. Zill, Eva Christalle, Björn Meyer, Martin Härter, and Jörg Dirmaier The Effectiveness of an Internet Intervention Aimed at Reducing Alcohol Consumption in Adults: Results of a Randomized Controlled Trial (Vorvida) Dtsch Arztebl Int 2019; 116: 127–33. DOI: 10.3238/arztebl.2019.0127