UbiPlus Develops Digital Treatment Device for Alcohol Use Disorder

As digital technology begins to be widely applied in the treatment of addictions, digital healthcare company UbiPlus is developing a digital therapeutic device, "A-STOP," to improve alcohol use disorder. "A-STOP" has completed confirmatory clinical trials, and the last patient last visit (LPLV) for the A-STOP confirmatory trial was also recently completed.

UbiPlus is currently consolidating data secured by each clinical trial site. It is also conducting verification of the consolidated data and statistical analysis of the consolidated data, and the specific clinical trial results are currently under analysis.

UbiPlus plans to prepare a final clinical trial report after data verification and statistical analysis are completed. It then plans to proceed with the Ministry of Food and Drug Safety's product approval process based on the final clinical trial report, and has begun preparations for the Ministry of Food and Drug Safety approval accordingly. Specific clinical trial results will be disclosed after the final results are finalized.

For the treatment of alcohol use disorder, nonpharmacological therapies such as medication and cognitive behavioral therapy are used in combination. However, in clinical settings, there are limits due to a shortage of specialized personnel and restrictions on access to treatment, leaving patients in a situation where it is difficult to secure sufficient treatment opportunities.

Because alcohol use disorder has a high risk of relapse and requires long-term management, the need for new treatment tools to improve continuity has continued to be raised. Against this backdrop, A-STOP, a software-based digital therapeutic device, is designed for patients with alcohol use disorder and aims to fill treatment gaps by having them carry out the program for a set period after a prescription from a medical professional.

A-STOP is configured to have users participate in a continuous treatment program in daily life for 12 weeks, and it is designed to carry out a range of therapeutic activities based on cognitive behavioral therapy. Through this, it aims to enable treatment to continue between outpatient visits, with improved treatment engagement and continuity as its core effects.

The company said data generated during program use can be used to determine whether patients are carrying out treatment and to assess their progress. It also said the data could be used in the future as material for product improvement and as data for medical professionals to track treatment progress.

If this trial leads to product approval, it could become a meaningful case for the domestic digital therapeutic device market in the field of addiction disorders. In South Korea, digital therapeutic devices targeting some conditions such as insomnia have been approved and are in use, but in the domestic addiction-disorder field, full-scale commercialization has not yet been implemented.

A UbiPlus official said the confirmatory trial was completed with the cooperation of the trial participants, researchers, and medical professionals. The company added that it plans to closely conduct the ongoing data verification and analysis, and to push ahead with the Ministry of Food and Drug Safety approval process based on objective results.

UbiPlus is not limiting the target of treatment support to alcohol use disorder alone, and for that purpose it is developing "D-STOP," a digital therapeutic device intended to support the treatment and recovery of patients with alcohol use disorder and patients with substance use disorder.

Source: IT DAILY · Kim Ho
Original: https://www.itdaily.kr/news/articleView.html?idxno=241649

References

• https://www.itdaily.kr/news/articleView.html?idxno=241649