Tranzyme Pharama

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.

SOURCE: Reglan Side Effects › Diabetic gastroparesis treatment shows well in clinical trials

Tranzyme Pharma’s

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

SOURCE: Reglan Side Effects › New treatment for gastroparesis granted FDA ‘fast-track’ status