Successful completion of AD04-103 pharmacokinetics (PK) study of AD04, corroborating bioavailability, dose proportionality, no food effect, and safety profile consistent with the use of Ondansetron.

The FDA’s feedback follows Adial’s submission on November 19, 2024, in which the Company sought the Agency’s guidance on the alignment of its AD04 formulation strategy and bridging approach.

Successful completion of AD04-103 pharmacokinetics (PK) study of AD04, corroborating bioavailability, dose proportionality, no food effect, and safety profile consistent with the use of Ondansetron.

Key Highlights Successful completion of AD04-103 pharmacokinetics (PK) study of AD04, corroborating bioavailability, dose proportionality, no food effect, and safety profile consistent with the ...

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“A key achievement was the completion of our pharmacokinetics study evaluating AD04, our investigational drug for the treatment of Alcohol Use Disorder. This study assessed the PK ...

The FDA has confirmed that Adial's proposed strategy, which utilizes data from the AD04-103 study and in vitro dissolution data to demonstrate equivalence between AD04's planned commercial ...

Zotac's new blog post is a good PSA for any prospective owners and a pretty good selling point for its own 50 series cards, not that it needed one, of course, with how limited stock has been thus far.