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New treatment for gastroparesis granted FDA 'fast-track' status
August 5th, 2009 by Jennifer Walker-Journey
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.
TZP-102 is an oral medication. Tranzyme’s equivalent medication, TZP-101, a drug given by IV in a hospital setting, has been put on hold by the company. While the drug showed promising results in phase II trials, the company hopes to buy time until the markets improve and the cost of capital drops.
Diabetic gastroparesis is a disorder in which the stomach takes too long to empty its contents. It affects people with both type 1 and type 2 diabetes. The condition is often treated with metoclopramide, sold in the U.S. under the brand name Reglan. Earlier this year, the FDA required manufacturers of metoclopramide to put a black box warning on the medication warning health care providers and consumers of the risk of a serious involuntary movement disorder known as Tardive Dyskinesia.
Patients who suffer from Tardive Dyskinesia experience such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, pucker and pursing of the lips and involuntary movements of the fingers. The condition is often irreversible even after medication has been stopped.
Analysts say a new treatment for diabetic gastroparesis would be welcome in an area where few treatments are currently available.
Source: Biz Journals
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