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

Reglan (metoclopramide) was approved by the Food and Drug Administration in 1979 for the short term treatment of various gastrointestinal disorders. But last year, after numerous adverse event reports, the FDA issued a black box warning – the strongest of its kind – on Reglan and generic versions of metoclopramide, stating that the medication had been linked to Tardive Dyskinesia. The movement disorder has been most often associated with some antipsychotic drugs, but about a third of the cases of Tardive Dyskinesia are linked to Reglan (metoclopramide).

An estimated two million people take metocloopramide, including children and infants. While it is approved to treat conditions such as severe heartburn, gastroesophageal reflux disease (GERD) and gastroparesis, or the delayed emptying of stomach contents, it also has an off-label use in the treatment of migraine headaches and morning sickness in women who are pregnant.

The makers of Reglan and generic versions of the drug are now facing numerous lawsuits from people like August, who are suffering permanent disability because of the drug. The Macalusoes allege they were never appropriately warned of the risk of developing Tardive Dyskinesia, and now it’s too late.

Source: News Observer

SOURCE: Reglan Side Effects › Man suffers permanent disability from heartburn drug

Patients who suffer from regular vomiting, stomach pain or trouble swallowing are usually given diagnostic tests such as endoscopies, biopsies and CT scans. Some patients are sent to other cities for more advanced testing. With the opening of El Paso’s new clinic, patients who suffer from serious gastrointestinal conditions have more options for specialized care.

“Rather than sending patients to the Mayo Clinic, we can take care of them right here,” says Dr. Richard McCallum, a gastroenterologist and chairman of the Department of Internal Medicine at El Paso’s medical school, in an interview with the El Paso Times. “We offer a very cutting-edge array of the best tests to diagnose the disorders.”

These tests include an esophageal motility test to measure the muscles and pressure of the esophagus; and a gastric emptying test and an ingestible SmartPill, both of which monitor how quickly food leaves the stomach. “These are a series of tests the average hospital and (doctor’s) office do not have,” Dr. McCallum says.

The center will also conduct medical students for new drugs and treatments for various gastrointestinal conditions, including gastroparesis, a condition in which the stomach empties its contents too slowly causing pain, disability and nutritional problems for those who suffer from the condition.

SOURCE: Reglan Side Effects › New medical center to focus on gastrointestinal disorders