Verification of market and regulatory conditions in the EU and global for a more effective treatment of alcohol-abuse

Purpose and goal:

Alcohol abuse is common and leads to serious consequences for the individual and society. Despite the fact that reduced alcohol abuse is an important medical treatment goal, only about 7% receive drug treatment today. Against this background, it is important to validate the needs of users (patients and doctors) and verify regulatory requirements regarding the global development program for the company´s drug candidate.The goals of the project are well met and have resulted in an in-depth customer knowledge, an overall development plan and expanded network and partnerships.

Expected results and effects:

The project has pointed out differences in treatment in different countries, and that the important product attributes are clinical effect and simple dosage.

The project has provided broad knowledge of regulatory guidelines for the authorization of drugs for the treatment of alcohol dependence in EU and US and has resulted in a regulatory strategy and robust clinical programme.

The project has verified a potential for a more effective drug for the treatment of alcohol dependence with the opportunity to create value for patients, doctors and society Approach and implementation:

During 2021, interviews with doctors and experts were conducted as well as in-depth literature studies to examine customers´ needs and eligibility requirements for a new treatment of alcohol abuse, with the aim of developing an overall development plan and clinical programme for the company´s drug candidate. The strategies and plans developed have been discussed with and validated by scientific experts in the clinical, medical and regulatory areas.