Novel gastroparesis drug gets fast track designation

Lisa Foster-McNulty, MSN, RN, CDE

What is Gastroparesis?

Folks who have gastroparesis have slow digestion of food.  The symptoms of gastroparesis include becoming full very quickly, nausea, vomiting, extreme feelings of fullness after eating, and pain in the upper abdomen.  About 29% of the population of people with the diagnosis have diabetic gastroparesis, and about 36% have what is called idiopathic gastroparesis–this is a fancy way of saying that the cause is unknown. 

A drug called velusetrag is being developed by a company called Theravance.
Theravance announced that the Food and Drug Administration (FDA) has given velusetrag Fast Track designation for treating the symptoms associated with both diabetic and idiopathic gastroparesis.  This medication is not yet available; it is still under study.  It is currently in a large, multinational Phase 2b study in patients who are confirmed to have either of these types of gastroparesis.  The study investigates three doses of velusetrag (5, 15, and 30 mg once daily for 12 weeks).  The primary endpoint of the study is the effect of this drug on symptoms in patients with gastroparesis.  An already-completed Phase 2 study demonstrated that velusetrag in all three doses was linked to a decrease in gastric emptying time, as compared to placebo.

Results from the current study should be available by mid-2017.  Fast Track designation gives Theravance development and regulatory advantages, so this should assist the company in their efforts to bring this drug to patients who, at present, do not have many effective treatment options.  If this drug is shown through clinical trials to be safe and effective, the Fast Track designation could help to make this available to patients in need much sooner than would otherwise be expected.