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Metoclopramide Nasal Spray Shows Promise for Diabetic Gastroparesis. Phase 2 study

Reuters – A phase 2b study has found intranasal delivery of metoclopramide to be more effective in managing symptoms of diabetic gastroparesis than oral metoclopramide, Evoke Pharma Inc said today.

The study compared the efficacy and safety of metoclopramide nasal spray dosed four times a day for six weeks to oral metoclopramide in 89 diabetic patients with symptoms of gastroparesis.

Gastroparesis is a condition in which the muscles of the stomach work slowly and lead to slow emptying of food from the stomach into the intestine. Diabetes is the most common cause for the condition.

Metoclopramide nasal spray provided better symptom control than oral metoclopramide,” the authors report in Neurogastroenterology & Motility, online now.

The side-effect profile of metoclopramide nasal spray was ”favorable. More side effects, especially nausea, occurred with the oral tablets,” they note.

”It is intuitive that a nasal spray will have more reliable absorption than a tablet in patients with delayed gastric emptying, Dr. Marilyn Carlson, Chief Medical Officer of Evoke Pharmaceuticals, said in a statement.

”These data from symptomatic diabetic gastroparesis patients confirm that metoclopramide nasal spray is well-tolerated and can offer better symptom relief than a tablet in this population,” she added. ”We believe the results from our Phase 2b clinical trial validate our novel intranasal delivery system of metoclopramide (EVK-001) which will be evaluated soon in our upcoming Phase 3 clinical trial,” said Dave Gonyer, President and Chief Executive Officer of Evoke.

”There haven’t been any new drugs for the management of symptoms associated with gastroparesis approved by the FDA since 1980, and there are very few drugs in clinical development for this debilitating diabetic complication,” he added.

Neurogastroenterol Motil Dec 2013.

From Reuters Health

 

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