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news.EVK-001, a formulation of metoclopramide that has been optimized for intranasal delivery and tolerability
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Evoke Pharma, a specialty pharmaceutical company, has initiated a Phase IIb clinical trial to evaluate EVK-001 for the treatment of adults with symptoms of diabetic gastroparesis.
The metoclopramide intranasal trial (MINT) is expected to enroll approximately 225 adult patients with diabetic gastroparesis at more than 25 clinical sites in the US.
This 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.
According to Evoke Pharma, EVK-001 is a 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 tract.
Dave Gonyer, CEO of Evoke Pharma, said: Given the significant clinical need and the limited treatments available, we recognize the importance of continuing to work closely with the FDA to bring the product to the market as soon as possible.
Encouraging results from previous studies with intranasal and marketed oral formulations of metoclopramide served as the basis for the company’s decision to conduct MINT, prior to initiating a confirmatory Phase III study.