Evoke’s Gimoti Approved for Diabetic Gastroparesis

FDA has approved an Evoke Pharma NDA for Gimoti (metoclopramide) nasal spray, indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The condition is associated with symptoms such as nausea, abdominal pain, bloating, early satiety, and vomiting which can be severe and debilitating, according to the company. Patients often have erratic absorption of orally administered drugs due to delayed gastric emptying, it says. The nasal administration is intended to bypass the diseased gastrointestinal track, allowing the drug to enter the bloodstream directly. Evoke says that potential adverse reactions associated with metoclopramide include: Tardive dyskinesia, other extrapyramidal effects, parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome, depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, and effects on the ability to drive and operate machinery.