Cannabis Use Disorder (CUD) is a psychiatric disorder recognized in international diagnostic systems such as the DSM-5, characterized by a problematic pattern of cannabis use leading to clinically significant impairment or distress despite negative consequences in personal, social or occupational functioning. Although cannabis is one of the most widely used substances worldwide, there are currently no medications specifically approved for the treatment of CUD. Existing approaches generally focus on psychosocial interventions or supportive clinical strategies. This situation defines a clear unmet medical need in the treatment of cannabis dependence and the clinical management of CUD.
The clinical program is developed in accordance with European standards of Good Clinical Practice (GCP) and with the regulatory framework applicable to research involving medicinal products in humans. The study design integrates clinical, ethical and pharmaceutical formulation considerations from early stages, with the objective of ensuring data quality and progressing in a structured manner toward evaluation in clinical settings.
Medical Flowers Developments is developing an investigational medicinal product specifically aimed at addressing Cannabis Use Disorder (CUD), intended for evaluation in clinical trials conducted in specialized healthcare settings focused on addiction treatment. The development integrates pharmaceutical formulation and clinical criteria from early stages, in dialogue with hospital clinical practice, and is aligned with the European regulatory requirements applicable to an Investigational Medicinal Product (IMP).
Medical Flowers Developments collaborates with pharmaceutical and biotech companies interested in cannabinoid clinical trials. The company maintains an open approach to professional discussions focused on development, innovation, and investment in regulated projects.
