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COVID-19 brings forward the need for digital therapies to help the millions of patients suffering from depression, alcohol misuse, and opioid addiction.
FREMONT, CA: Orexo AB trumpets the US launch of its scientifically proven digital therapies deprexis and vorvida for the treatment of symptoms of depression and management of problematic alcohol misuse, respectively. Deprexis is available to patients from July 1st and vorvida from July 15th. The decision to accelerate the launch is based on the requirement for access to low-risk clinically-validated digital health devices during the ongoing COVID-19 pandemic and the recent US Food and Drug Administration (FDA) "Enforcement Policy" offering a fast pathway to market for digital therapies for the treatment of psychiatric disorders. As a result of the "Enforcement Policy" the development of OXD01, a digital therapy for the treatment of opioid use disorders, will be accelerated and tested in partnership with selected customers in Q4 2020, in preparation of a broad launch in Q2, 2021, a year ahead of the original plan.
COVID-19 pandemic is expected to have a large negative impact on mental health, which highlights the need for countries to take necessary measures to reduce its impact on individuals, their families, and society more broadly. Realizing the need for additional treatment solutions for rising mental health conditions, the FDA has introduced an "Enforcement Policy" with the objective of increasing access to digital therapies within the area of psychiatric disorders during the pandemic.
To capture the patient need arising from the COVID-19 pandemic and accelerate the commercialization, Orexo will use the company's strong financial position to invest in the early launch of the digital therapies during 2020. The new OPEX guidance for 2020 is increased to SEK 750-800 million from SEK 550-600 million, reflecting investments related to the accelerated commercialization and establishment of the DTx business. Except for depreciation, the OPEX guidance does not include capitalized investments such as the previously communicated investments related to the acquisition of the rights to deprexis® in the US and other one-time investments related to the digital therapeutics of approximately SEK 115 million. Initial revenues from digital therapeutics are expected in Q3 2020, and total net revenues in 2020 from digital therapies are dependent on the pace Orexo can secure product reimbursement.