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Evoke submits NDA for diabetic gastroparesis therapy
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Evoke Pharma has submitted a new drug application to the FDA for Gimoti, a nasal-spray formulation of the dopamine-receptor antagonist metoclopramide for management of diabetic gastroparesis symptoms in women, the company announced in a press release.
Gastroparesis may result from diabetic neuropathy of the vagus nerve. The condition causes delayed gastric emptying with vomiting, nausea, bloating and abdominal pain. Up to 80% of adults with the condition are women, according to the release.
“Vomiting and gastric emptying delays cause unpredictable absorption of food and oral medications, which complicates glucose control and can lead to dehydration and malnutrition. Existing oral treatment options may be ineffective during an acute flare, which we believe creates the need for a nonoral treatment option,” Dave Gonyer, president and CEO of Evoke, said in the release.
The company expects notification in August about whether the FDA will accept the NDA for substantive review.