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news.US-based Evoke Pharma has started a thorough double-blind, double-dummy, four-way crossover ECG (QT) study of its lead product candidate, EVK-001, which is currently in a Phase III clinical trial for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus.
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The ECG (electrocardiogram) study in healthy volunteers is designed to evaluate the effect of EVK-001 on cardiac ventricular repolarization, specifically the QT-interval.
The study will be carried out in accordance with US Food and Drug Administration (FDA) E14 Guidance and its protocol has been reviewed by the FDA. It is being conducted to meet the FDA’s requirements for submission of a new drug application (NDA) for EVK-001.
Evoke chief medical officer Marilyn Carlson said the company is happy to have initiated the thorough ECG study of EVK-001, its intranasal delivery formulation of metoclopramide for the treatment of women with diabetic gastroparesis.
"This brings us another step closer to fulfilling the requirements for the EVK-001 NDA," Carlson said.
"Since the oral formulation of metoclopramide was first approved in 1980, millions of doses have been administered to patients of all ages for a range of indications with no signs that there are cardiovascular safety issues associated with the drug.
"With the thorough ECG (QT) study now underway, we expect to be able to provide top-line data in early 2015."