Clinical trial underway for metoclopramide nasal spray
May 22nd, 2009 by Jennifer Walker-Journey
Questcor Pharmaceuticals Inc. has just released the study results of its Phase II clinical trial on a metoclopramide nasal spray for the treatment of diabetic gastroparesis, a condition in which contents remain in the stomach for a longer period of time than normal. Left untreated, gastroparesis can lead to fluctuations in blood glucose, general malnutrition, intestinal obstruction and bacterial infection.
Diabetes is just one of the known causes of gastroparesis. The condition is generally treated through dietary changes and medications including metoclopramide, which is commonly found under the brand names Reglan, Maxolon or Clopra and is traditionally available in the form of a tablet, oral solution or injection.
The clinical trail on Questor’s Emitasol metoclopramide nasal spray showed encouraging results in terms of safety and preliminary evaluation of efficacy in the treatment of diabetic gastroparesis. No serious adverse events were reported during the trial.
In recent months, the Food and Drug Administration (FDA) placed a black box warning on the drug metoclopramide – the strongest warning required by the FDA – after a serious condition called Tardive Dyskinesia was reported in a number of patients who took the drug. Tardive Dyskinesia is a Parkinson’s-like condition in which a person develops involuntary movements of his muscles, including lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, lip puckering and involuntary movements of the fingers. The condition can be permanent, even after the drug has been discontinued.
Questor says it plans to begin Phase III of the Emitasol study as soon as possible.
Source: PR Newswire