Adial Pharmaceuticals submits briefing package to guide upcoming FDA meeting

Adial Pharmaceuticals (ADIL) announced the submission of the required briefing package for the upcoming End of Phase 2 meeting with the Food and Drug Administration. The FDA has rescheduled the meeting which will now be held on July 29th. The briefing package, a prerequisite for the EOP2M, must be submitted in advance to allow for FDA review and preparation ahead of the meeting. AD04 is Adial’s lead investigational drug, a serotonin-3 receptor antagonist, being developed for the treatment of Alcohol Use Disorder in individuals with heavy drinking and select genotypes. The objective for the EOP2M is to align with the FDA on the design of the Phase 3 Clinical Development program for AD04. This includes key elements of the planned adaptive study design elements, such as population, endpoints, inclusion/exclusion criteria, dose regime, and affirmation of the biomarker positive and biomarker negative groups. The briefing package is based on a comprehensive package, including legacy safety data, efficacy studies performed by Adial, and the data analysis conducted in collaboration with Cytel. Adial worked together with Quantum Regulatory Solutions, LLC, a clinical and regulatory strategy advisor and Cytel, to develop the Phase 3 protocol, the statistical analysis plan, the briefing package, and related documents for the meeting. A outcome from the EOP2M will not only provide critical regulatory alignment to advance AD04 into Phase 3 but is also expected to play a pivotal role in Adial’s ongoing strategic partnering efforts. Clarity and validation from the FDA on the clinical development path are anticipated to significantly strengthen Adial’s position in discussions with potential partners, who typically view regulatory momentum as a key de-risking milestone in the decision-making process.