Tranzyme Pharma today announced that the 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.
