Until recently, gastroparesis treatment was a largely unmet need in the U.S., but now is back in the forefront.
Here's what you should know:
1. The pharmaceutical and device industries renewed efforts to develop gastroparesis treatments. Current treatment approaches include prokinetics, metoclopramide, domperidone and erythromycin.
2. The FDA issued new guidance relating to gastroparesis research. The guidelines dictate that studies should have a one to two week baseline, followed by a 12 week treatment period and a two to four week randomized withdrawal period. The guideline suggests a study period of at least 12 months.
3. Researchers have established "meaningful endpoints." These endpoints were developed and validated and should guide treatment plans. Treatments should be evaluated against the Gastroparesis Cardinal Symptom Index and on an equal-interval scale.
4. The American Gastroenterological Association issued a statement for providers to give to their patients: "There is a renewed focus on finding a treatment for gastroparesis that will alleviate your symptoms and improve your quality of life."
For more information on gastroparesis, the AGA published a white paper in Clinical Gastroenterology and Hepatology, click here.