FDA Fast Track Status For Oral GI Prokinetic Drug Candidate TZP-102 - For Gastroparesis In Diabetic Patients

Main Category: Diabetes
Also Included In: GastroIntestinal / Gastroenterology;  Regulatory Affairs / Drug Approvals
Article Date: 28 Jul 2009 - 0:00 PDT

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Tranzyme Pharma announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's oral gastrointestinal (GI) prokinetic drug candidate TZP-102, for the treatment of gastroparesis in diabetic patients. According to the FDA, gastroparesis is a serious complication of diabetes mellitus that affects approximately 30-60% of diabetic patients.

Fast track designation is designed to facilitate development and expedite review of a drug candidate that treats a serious or life-threatening condition and addresses an unmet medical need. In their approval letter, the FDA noted there are limited treatment options for diabetic gastroparesis and agents currently available have serious side effects. TZP-102 qualifies as a potential treatment for this extremely serious condition.

"We are extremely pleased that TZP-102 has received the FDA's designation as a Fast Track product," commented Gordana Kosutic, MD, Tranzyme's Vice President of Clinical and Regulatory Affairs. "We routinely hear from patients suffering from gastroparesis who are excited about the progress of our clinical programs and hopeful that a safe and effective therapy is forthcoming. Being granted Fast Track status is another milestone in helping to meet that need."

Tranzyme is currently enrolling patients in a multi-national Phase 2, randomized, double-blind, placebo-controlled study of TZP-102. The outcomes will evaluate the safety and efficacy of TZP-102 in accelerating gastric emptying and improving symptoms of gastroparesis in diabetic patients.

About Gastroparesis

Gastroparesis is an impairment or paralysis of upper gastrointestinal tract function characterized by delayed gastric emptying in the absence of mechanical obstruction. It is a significant complication of diabetes mellitus and symptoms include nausea, vomiting, loss of appetite and early satiety, and may affect nutrient delivery to the small intestine with resultant fluctuations in blood glucose levels, loss of weight, and malnutrition. Gastroparesis may also result from abdominal surgery or be idiopathic in nature. The only FDA approved drug for gastroparesis is metoclopramide, for which the FDA recently ordered a "black box" warning due to the risk of often irreversible tardive dyskinesia (involuntary movement disorder). In spite of these severe side effects, more than 2 million patients use the drug in the U.S. alone. Cisapride, formerly used widely in the treatment of gastroparesis, has been removed from the market owing to safety issues.

About TZP-102

TZP-102 is a novel, orally administered prokinetic agent that acts by a mechanism distinct from previously developed products for gastrointestinal (GI) motility disorders. TZP-102 is a second generation agonist of the ghrelin receptor, which is distributed in both the upper and lower GI tract. TZP-102 has the potential to treat gastroparesis and other GI and motility disorders, including GERD, functional dyspepsia, opioid bowel dysfunction and irritable bowel syndrome with constipation. TZP-102 originated from Tranzyme's proprietary MATCH™ drug discovery technology.

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Tranzyme Pharma