In the US Orexo has launched the digital therapies deprexis and vorvida, for the treatment of depression and management of alcohol misuse respectively.
Deprexis is available to patients now and vorvida from 15 July. The launch has been boosted by the US Food and Drug Administration (FDA) Enforcement Policy, which provides a fast pathway to market for digital therapies for treatment of psychiatric disorders, and patient need to access low-risk clinically-validated digital health therapies during the COVID-19 lockdown.
The COVID-19 pandemic, with society lockdowns and social distancing is expected to lead to a significant increase in mental health issues and substance use disorders. A report published by ODMAP (Overdose Detection Mapping Application Program) indicates a double-digit percentage increase in the number of overdoses in the US related to COVID-19. In addition, a recently published report by World Health Organization (WHO) suggests COVID-19 is expected to have a large negative impact on mental health, highlighting the need for countries to take necessary measures to alleviate the impact on individuals, their families and society more broadly. Recognising the need for additional treatment solutions for rising mental health conditions, the FDA has introduced an Enforcement Policy with the aim of increasing access to digital therapies within the area of psychiatric disorders during the COVID-19 pandemic.
Nikolaj Sørensen, President and CEO at Orexo AB said: “Due to the COVID-19 pandemic, the need for clinically validated digital therapies is unprecedented. This pressing need, combined with the FDA’s measures to expand availability of digital therapies for psychiatric disorders, have accelerated launch plans for Orexo’s digital offering. This aligns with our strategy to increase our product offering and to further leverage our commercial US infrastructure. Orexo has a profitable and well-funded pharmaceutical business enabling the investment required to capitalise on the current digital therapies opportunity, drive longer term growth and address patient need.”