Diabetic gastroparesis treatment shows well in clinical trials
July 15th, 2010 by Jennifer Walker-Journey
Tranzyme Pharama says its new treatment for diabetic gastroparesis, a disabling disorder in which the stomach takes too long to empty its contents, has shown positive results in phase II clinical trials among diabetic patients with the digestive disorder. The pharmaceutical company was granted “fast-track status” by the Food and Drug Administration (FDA) for TZP-102, a designation that is typically reserved for drugs that treat serious and unmet medical needs. The designation is designed to speed up the review and approval process.
Tranzyme Pharma’s drug candidate would be an alternative to a drug for gastroparesis that now carries a black box warning. Reglan (metoclopramide) is a prescription treatment for gastroparesis that just recently received an FDA black box warning following reports that linked the medication to a serious and involuntary movement disorder known as Tardive Dyskinesia. A black box warning is the most serious type of warning the agency can issue and is reserved for drugs that carry a significant risk of serious or even life-threatening adverse events.
Alternatively, Tranzyme Pharma reported that all three doses of TZP-102 were effective, safe and well tolerated by participants in the clinical trial. The company is now gearing up for a 12-week study to test the drug’s efficacy and safety in patients who have gastroparesis.
Last month, Tranzyme Pharma announced an agreement with Netherlands-based Norgine to develop and commercialize TZP-101, another treatment for gastrointestinal disorders.