New treatment for gastroparesis granted FDA ‘fast-track’ status
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.