Press Releases, Pharmaceutical

Aptar Digital Health and Moffitt Cancer Center Launch Clinical Evaluation for Oncology Digital Therapeutic

The clinical evaluation, which will primarily assess the usability of Aptar Digital Health’s digital therapeutic in oncology, Oleena® will begin in February 2024 and run for a total period of 15 months.

Press Release
By Ciara Jackson Senior Marketing Manager, Aptar Pharma
18 Jan 2024

Aptar Digital Health, a global expert in Software as a Medical Device (SaMD), digital Patient Support Programs (PSPs) and disease management solutions, today announced a collaboration with Moffitt Cancer Center, a leading U.S. cancer care and research institution, to conduct a clinical evaluation of Oleena®, Aptar Digital Health’s digital therapeutic (DTx) for the management of symptoms in cancer care, which is authorized by the U.S. Food and Drug Administration (FDA) and CE Marked.

The clinical evaluation, which will begin in February 2024 and run for a total period of 15 months, will primarily assess the usability of Oleena® by measuring key indicators such as patient satisfaction and engagement, as well as clinical outcomes including symptom burden, anti-cancer treatment adherence and quality of life.

Under this clinical evaluation, head and neck cancer patients being treated with chemoradiation will use Aptar Digital Health’s Oleena® DTx to guide them in self-managing their symptoms. The Oleena® DTx allows patients to enter and track their symptoms and receive personalized clinical recommendations based on their individualized treatment plan. The Oleena® DTx supports patients on how to react when various symptoms arise, including fluctuations in body temperature and breathing, coughing, skin irritations, weight change, fatigue, nausea, vomiting and others. Oleena® automatically transfers data entered in the mobile app to a dedicated web portal, allowing the health care teams to remotely monitor their patients.

Oleena by Aptar Digital Health - the first-in-class digital therapeutic in oncology authorized in the US and Europe

Aptar Digital Health’s Oleena® digital therapeutic in oncology is authorized in the US and Europe

“At Moffitt, we’re dedicated to providing top-notch care to our patients in a timely manner. Remote symptom monitoring is a great way for us to quickly detect any potential issues and take proactive action to prevent the symptoms from advancing,” said Amir Alishahi, MD, PhD, MPH, Assistant Member, Department of Health Outcomes and Behavior, Moffitt Cancer Center.

“Aptar Digital Health’s collaboration with Moffitt Cancer Center, recognized for its scientific excellence, multidisciplinary research and robust training and education, demonstrates how digital health is becoming a key driver in disease management,” stated Geneviève d’Orsay, Chief Medical Officer, Aptar Digital Health. “Providing patients with decentralized and easy-to-use tools outside clinical settings to assist them in the daily management of their disease is essential to help reduce treatment discontinuation.”

Pierre Leurent, President, Aptar Digital Health, added, “Treatment toxicities remain a key reason why patients discontinue their therapy, and symptom management is the most performed task by clinical teams. Providing solutions that address these challenges is paramount to delivering an enhanced patient experience.”

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