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Pozen is developing a chemical compound designed to provide the heart-protecting effects of aspirin without increasing the risk of stomach ulcers, a common side effect.
The company said that the FDA responded to its proposal for late-stage testing of the drug by suggesting it conduct an additional study of how its drug is absorbed in the human body. The drugmaker already submitted one study to FDA showing its drug is absorbed and metabolized in a similar manner to aspirin.
Companies typically consult with FDA before starting late-stage studies of their drugs. FDA is responsible for assuring the safety and effectiveness of all drugs marketed in the U.S.
Shares of Pozen fell 46 cents, or 3.8 percent, to $11.61 in aftermarket trading, after closing the regular session down 11 cents at $12.07.
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