Evoke Pharma, Inc. Initiates Phase 2b Metoclopramide Intranasal Trial (MINT) in Patients With Diabetic Gas... ( SAN DIEGO May 5 /-

Evoke Pharma, Inc. Initiates Phase 2b Metoclopramide Intranasal Trial (MINT) in Patients With Diabetic Gastroparesis

Date:5/5/2009

SAN DIEGO, May 5 /PRNewswire/ -- - Evoke Pharma, Inc., a privately-held specialty pharmaceutical company, announced today that it has initiated a Phase 2b clinical trial to evaluate EVK-001 for the treatment of adults with symptoms of diabetic gastroparesis. Gastroparesis is a syndrome characterized by delayed emptying of the stomach into the intestine following a meal in the absence of mechanical obstruction. Diabetes is an important cause of gastroparesis, but other identified causes include previous abdominal surgery, neurologic conditions, and infection. Symptoms associated with gastroparesis include: fullness after eating a small amount of food, nausea, vomiting, and bloating. In addition to diminished quality of life for all sufferers, gastroparesis symptoms increase a diabetic patient's risk of life-threatening complications from malnutrition and erratic blood sugars.

The Metoclopramide Intranasal Trial (MINT) is expected to enroll approximately 225 adult patients with diabetic gastroparesis at more than 25 clinical sites in the United States. The randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of two doses of EVK-001 over four weeks. The severity of symptoms associated with diabetic gastroparesis and the impact of gastroparesis on quality of life will be evaluated before and after EVK-001 administration.

EVK-001 is a proprietary formulation of metoclopramide that has been optimized for intranasal delivery and tolerability. Unlike tablet formulations, EVK-001 is designed to deliver a systemic dose of metoclopramide that does not depend on absorption from the gastrointestinal (GI) tract.

"Given the significant clinical need and the limited treatments available, we recognize the importance of continuing to work closely with the Food and Drug Administration (FDA) to bring the product to the market as soon as possible," states Dave Gonyer, R.Ph., Chief Executive Off
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Evoke Pharma, Inc. Initiates Phase 2b Metoclopramide Intranasal Trial (MINT) in Patients With Diabetic Gas...( SAN DIEGO May 5 /- - Evoke Pharma Inc...)