DTx Receives FDA’s Breakthrough Device Designation for Anxiety and Depression Symptoms Associated With Cancer

The specialized device is being studied for patients receiving inpatient care for acute myeloid leukemia.

A prescription-only digital therapeutic was granted breakthrough device designation by the US Food and Administration for the treatment of anxiety and depressive symptoms created by psychological stressors experienced by adults with acute myeloid leukemia (AML) who are hospitalized and undergoing high-intensity induction (HIC) chemotherapy.1

Known as BNT200, the device was developed for use in the inpatient setting during the 4 to 6 weeks in which HIC treatment is administered. The content is synchronized with the HIC regimen to dull the stressors endured by this patient population. The application for BNT200 was supported by data demonstrating the device’s usability and preliminary efficacy. Blue Note’s digital therapeutics leverage cognitive behavioral stress management tailored for patients with cancer.2

Areej El-Jawahri, MD, associate director of the Cancer Outcomes Research and Education Program and associate professor of medicine at Massachusetts General Hospital, stated in a press release: “The advancement of innovative therapeutic options for the treatment of the associated distress that often follows a diagnosis is promising for patients and addresses an unmet need.”1 El-Jawahri is the principal investigator of a trial evaluating the impact of the device on quality of life (QoL), mood, and symptoms of patients diagnosed with AML.

It has been estimated that half of patients with cancer experience psychosocial distress, anxiety, or depression, and less than half of patients who experience cancer-related distress are referred for mental health care.2

“We are pleased that the FDA has recognized the need to speed up development and review of BNT200, as well as encouraged by our ability to help reduce the symptoms of distress and improve QoL and care in patients with newly diagnosed AML,” Geoffrey Eich, chief executive officer of Blue Note Therapeutics, added in the press release.1

An earlier version of this article appeared on Psychiatric Timessister publication OncLive.

References

1. Blue Note Therapeutics receives breakthrough device designation for prescription-only digital therapeutic for acute myeloid leukemia. News release. Blue Note Therapeutics; January 2022. Accessed January 11, 2022. https://bluenotetherapeutics.com/news/blue-note-therapeutics-receives-breakthrough-device-designation-for-prescription-only-digital-therapeutic-for-acute-myeloid-leukemia/

2. Cancer-related distress. Blue Note Therapeutics website. Accessed January 11, 2022. https://bluenotetherapeutics.com/why/