Adial Pharmaceuticals secures U.S.-based manufacturing through agreements

Adial Pharmaceutical (ADIL) announced the recent execution of agreements for the production of AD04, supporting both the completion of upcoming clinical trials and the planned New Drug Application, NDA, submission to the U.S. Food and Drug Administration, FDA, for the treatment of Alcohol Use Disorder, AUD, in the US. AD04 is the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of AUD in heavy drinking patients. The strategic collaboration with Thermo Fisher Scientific (TMO) as the Contract Development and Manufacturing Organization, CDMO, for AD04 Drug Product, and Cambrex, a drug substance CDMO and supplier of Ondansetron API, has begun and is already seeing results in completion of the demonstration batches required prior to the conduct of the registration and clinical batches. The agreements include all phases of manufacturing for both the clinical supplies needed to conduct the upcoming clinical studies for AD04, as well as the Chemistry, Manufacturing, and Controls module documentation required for the submission of the NDA to the FDA.