FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Guidance on Combination Hypertension Drugs Offers Alternatives to Larger Trials

Jan. 29, 2018
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Drug sponsors can prove the effectiveness of combination drugs for treatment of hypertension with trials that test the highest approved dosage rather than trials with multiple doses, the FDA said in new draft guidance for developing such products.

Instead of calling for large studies involving multiple doses of each component, the guidance offers alternatives for demonstrating the components’ independent contributions — either comparing the effect of the combination to the separate components at their highest approved doses, or comparing them at the highest doses planned for the fixed combination.

While the guidance assumes two components, it can be applied to combinations of three or more.

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