Diabetic gastroparesis treatment shows well in clinical trials
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.
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Tranzyme Pharma’s new drug to treat diabetic gastroparesis has been granted a fast-track designation by the Food and Drug Administration (FDA), allowing it faster access to FDA personnel as it moves through the approval process. The new medication, called TZP-102, has just moved into phase II trials in humans. If the trials run smoothly, the drug should enter phase III trials next year with approval by 2013 at the earliest. The fast-track designation is reserved for drugs that treat serious and unmet medical needs.