Tranzyme Drug Candidate Receives FDA Fast Track Status

Research Triangle Park, N.C. — The U.S. Food and Drug Administration has granted “fast track” status to a drug that targets a digestive condition known as gastroparesis and that Tranzyme Pharmaceuticals is testing.

The drug compound is known as TZP-101.

“Fast track” status can lead to expedited review of a drug that targets a serious or life-threatening condition and has the potential to deal with an unmet medical need.

Tranzyme’s compound received the “fast track” status based on a Phase IIa clinical study of diabetic patients suffering from severe gastroparesis.

“The Food and Drug Administration’s fast track designation for TZP-101 highlights the large unmet medical need for a treatment for severe gastroparesis,” said Gordana Kosutic, vice president of clinical and regulatory affairs at Tranzyme.

“In 2005, an estimated 150,000 patients were hospitalized with a diagnosis code of gastroparesis; these patients had gastroparesis listed as either a primary or secondary diagnosis at the time of discharge,” he added. “Many of these patients are diabetics who have inadequate blood glucose control. Currently, no satisfactory treatment exists for this severe condition.”

A drug known as Metoclopramide has been approved for gastroparesis but can trigger side effects, Kosutic said.

Gastroparesis involves delayed emptying of food from the stomach, which can lead to dysfunction of nerves in the stomach.