The FDA released final guidance for sponsors of fixed-combination hypertension drugs, with several clarifications of the draft document.
The guidance calls for a single phase III randomized trial to determine if combinations of previously approved blood pressure meds are effective. Studies should include participants likely to benefit from two-drug therapy, the FDA says. The agency notes that sponsors should see significant effects on both systolic and diastolic blood pressure — a clarification from the draft guidance, which simply suggested using one of the two blood pressure measures, or their mean, as a primary endpoint.
The FDA expanded a provision encouraging sponsors to market dose combinations that represent clinically meaningful titration steps to direct sponsors that intend to market multiple dose combinations to “avoid marketing excessive numbers of combinations whose components exert similar blood pressure effects,” such as a 5 mg/10 mg combination and a 7.5 mg/12.5 mg combination that lead to similar declines in blood pressure.