Tranzyme Pharma, a developer of drugs targeting gastrointestinal and metabolic diseases, has received fast track status from the U.S. Food and Drug Administration for a compound called TZP-101.
TZP-101 could be a treatment for sever gastroparesis, or a digestive disorder, and post-operative ileus, of blockage of the intestine.
The fast track program is designed to expedite review of drugs that could treat a serious or life-threatening disease and demonstrates the potential to deal with an unmet medical need. The ruling was based on Phase IIa clinical data that included treatment of diabetic patients with severe gastroparesis as well as pre-clinical studies.
“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, the 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.”
One approved treatment for the condition called Metoclopramide is associated with unwanted adverse events, Kosutic said.
