Evoke Pharma, Inc. Provides Additional Data from the Phase 3 Trial of Gimoti
January 04, 2017 at 07:00 pm IST
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Evoke Pharma, Inc. provided additional data from the Phase 3 trial of Gimoti, its nasal delivery of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. Although the Phase 3 trial failed to reach its primary endpoint, data also demonstrated that patients with moderate to severe symptoms, which included 105 of the 205 patients (51%) enrolled in the study, responded statistically significantly better when treated with Gimoti than those treated with placebo at multiple time points in the Intent-to-Treat (ITT) and Per Protocol populations. There were also clinically and statistically significant improvements in nausea and abdominal pain, which are two of the more severe and debilitating symptoms of gastroparesis. The Phase 3 safety data revealed no significant adverse effects and were consistent with favorable results from previous Gimoti studies. In particular, there were no adverse events of special interest, such as the central nervous system (CNS) effects observed with oral and parenteral metoclopramide.
Evoke Pharma, Inc. is a specialty pharmaceutical company. The Company is focused primarily on the development and commercialization of drugs to treat gastrointestinal (GI) disorders and diseases. The Company operates through the development and commercialization of pharmaceutical products. It is developing its product, Gimoti (metoclopramide) nasal spray, the first and only nasally administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. It developed Gimoti, a dopamine antagonist / mixed 5-HT3 antagonist / 5-HT4 agonist with pro-motility and anti-emetic effects, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. Gimoti is a novel formulation of metoclopramide offering systemic delivery by nasal spray administration. It has developed the nasal formulation of metoclopramide to provide its targeted patient population with acute or recurrent symptoms of diabetic gastroparesis.