Orexo and GAIA Partner to Develop a Novel Digital Therapeutic for Opioid Use Disorder

On August 21, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that pharmaceutical company Orexo announced a commercial partnership with digital health company GAIA to jointly develop and commercialize a novel digital therapeutic (DTx) for opioid use disorder (OUD).

Under the terms of the agreement, Orexo will hold exclusive global commercialization rights upon completion of the digital therapeutic’s clinical development. Furthermore, the company plans to submit a marketing application for the digital therapeutic to U.S. regulatory authorities in 2022.

Opioid Use Disorder (OUD) is a treatable chronic disease characterized by behavioral or psychological impairments—such as increased drug tolerance, respiratory depression, psychomotor retardation, and memory impairment—resulting from the use of opioids including morphine, heroin, methadone, and pethidine. Withdrawal symptoms include anxiety, insomnia, nausea and vomiting, muscle pain, and fever. Patients with OUD typically require psychotherapy and medication-assisted treatment; however, the risk of relapse remains high.

Digital therapeutics integrate advanced technologies related to drug design, clinical trials, usability, and data security to deliver safe and effective interventions for the prevention, management, or treatment of diseases. These therapies can be used independently or in conjunction with medications, medical devices, or other treatments to improve patient health outcomes. By providing high-quality, safe, and effective data-driven interventions, digital therapeutics offer treatment solutions for patients and healthcare providers addressing a wide range of diseases.

Orexo, founded in 1995 and headquartered in Uppsala, Sweden, is a leading integrated pharmaceutical company. The company develops new drugs for addictive disorders such as opioid use disorder (OUD) and researches novel drug delivery technologies to help patients manage substance addiction. Orexo was listed on the Stockholm Stock Exchange in 2005 under the ticker symbol ORX.

Orexo’s Zubsolv was approved by the FDA in July 2013 as an adjunctive treatment for patients with opioid dependence. The company states that, compared with other buprenorphine/naloxone products, Zubsolv offers higher bioavailability, rapid dissolution, and a smaller tablet size. The drug’s net sales totaled SEK 783.1 million in 2018.

GAIA is a global leader in the field of digital therapeutics, founded in 2001 and headquartered in Hamburg, Germany. The company’s digital therapeutics span multiple disciplines, including neuroscience, immunology, oncology, and behavioral health. As one of the largest and most experienced digital health companies worldwide, GAIA employs over 140 experts in medicine, psychology, behavioral medicine, and software engineering.

GAIA works closely with international healthcare and pharmaceutical companies such as Pfizer, Merck, AbbVie, B. Braun, Ferring Pharmaceuticals (Sweden), Lundbeck (Denmark), and Servier (France) to jointly develop digital therapeutics.

Nikolaj Sørensen, President and Chief Executive Officer of Orexo, stated, “GAIA possesses advanced technology and specialized expertise in the field of digital therapeutics, and Orexo is pleased to enter into this collaboration agreement. I believe that developing digital therapeutics for patients with opioid use disorder (OUD) will become a new trend in healthcare. Furthermore, Orexo will continue to collaborate with GAIA in other disease areas.”

Dr. Mario Weiss, Founder and CEO of GAIA, stated, “GAIA has nearly 20 years of development experience in the digital health sector. We aim to combine our digital therapeutics with Orexo’s expertise in pharmaceutical R&D to leverage innovative technologies for improving patient outcomes.”

(Compiled by Xu Xiaoxue)