United Therapeutics Faces Likely Regulatory Delay

SILVER SPRING, Md. (AP) — United Therapeutics Corp. said Monday it will likely face regulatory delays for the inhaled version of its hypertension drug Remodulin because of Food and Drug Administration concerns over patient instructions.

The company had expected a decision from the FDA by April 30, but will likely face delays because of questions over instructions for using the nebulizer that delivers the drug.

United Therapeutics already sells the drug as an injection called Remodulin. The inhaled version is called Tyvaso.

"Following our most recent discussion with the FDA, we have agreed to conduct human factors testing to validate that the revised instructions for use (IFU) results in the proper use of the device by a naive user," said President and Chief Operating Officer Roger Jeffs, in a statement. "This relatively small study in normal subjects will test the new IFU in its ability to guide patients to accomplish such tasks as proper device assembly, drug administration, disassembly and cleaning, among other things."

Shares of United Therapeutics sank $2, or 3 percent, to $66.28 in premarket activity.