Swedish pharma company Orexo is jumping into the American digital-therapeutics game with the announcement of two new products, deprexis for treating depression symptoms and vorvida, a treatment for problematic alcohol use.
The new treatments are coming to the US market thanks to relaxed FDA regulations surrounding digital health products for psychiatric disorders, which was enacted as a result of the coronavirus pandemic.
The company said that, with the FDA’s temporary policy change, it is also fast-tracking the development of its digital therapeutic of opioid use disorder, dubbed OXD01, for Q4 2020.
Both of the digital therapeutics employ artificial intelligence systems in order to deliver the treatment.
WHY IT MATTERS
Depression and alcohol use disorder are both common conditions. The World Health Organization, reports that approximately 265 million people globally are living with depression, and that the condition is a leading cause of disability in the world.
Alcohol use disorder also impacts many around the world. In fact, in the US 14.4 million adults in the use experience the disorder.
While the COVID-19 pandemic has created barriers to in-person care, many are pitching technology as a way to help reach individuals in their home.
“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,” Nikolaj Sørensen, president and CEO of Orexo AB, said in a statement. “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 capitalize on the current digital therapies opportunity, drive longer term growth and address patient need."
THE LARGER TREND
Digital therapeutics is a growing industry inside the world of healthcare. One of the biggest names in the space is Pear Therapeutics. In 2017 it landed an FDA de novo clearance for its reSET system, which is focused on substance use disorders. This was shortly followed by the clearance of reSET-O, an opioid use disorder therapy. The company made a deal with Novartis to commercialize the products, but in October the two broke ties, and Novartis gave commercialization responsibilities back to Pear.
In April, it took advantage of the FDA's loosening up of regulations for digital psychiatric-disorder devices during the coronavirus crisis and rolled out its new therapeutic aimed at treating schizophrenia. It also landed clearance for Somryst, a prescription digital therapeutic for chronic insomnia, which was the first to be evaluated through the FDA's Digital Health Software Precertification Program.