striking one snag after another! The new drug for gastropathy is accepted after being submitted to the market again

Today, Evoke Pharma, which focuses on the development of gastrointestinal medicine, announced that the US FDA had accepted the new drug application (NDA) of its Gimoti nasal spray, which was re submitted It is expected that FDA will respond in June 19th of this year Gimoti is mainly used to relieve the symptoms of adult women with acute and recurrent diabetic gastroparesis According to the press release, if approved, gimoti will become the first non oral outpatient treatment for symptoms related to acute and recurrent diabetic gastroparesis in adult women, which represents a significant progress in the treatment of gastroparesis in the past 40 years Gastroparesis is a disease characterized by delayed gastric emptying Its clinical manifestations are gastric distention, early satiety, nausea, vomiting, etc severe patients will have dehydration, electrolyte imbalance, malnutrition and weight loss Generally, the disease can be diagnosed by barium meal or radioisotope labeled gastric emptying test Diabetic gastroparesis affects millions of patients all over the world It may lead to serious digestive system symptoms, loss of blood glucose control and systemic complications Metoclopramide is currently the only drug approved in the United States for the treatment of gastroparesis, but only in the form of oral and injection Delayed gastric emptying caused by gastroparesis impairs the absorption of oral drugs Therefore, patients need a non oral drug to treat the disease Photo source: evoke website Gimoti is a nasal spray for metoclopramide, which can replace oral administration and injection There are abundant blood vessels in the epithelial cell layer of nasal mucosa, which can deliver metoclopramide molecules directly to the whole body In this way, the drug does not need to be metabolized by the liver, so the utilization rate of the drug is improved In a previously published randomized, double-blind, placebo-controlled phase 3 trial, gimoti's treatment showed clinical benefits for patients with moderate to severe symptoms compared to the placebo group Importantly, in the 28 day trial, the two most debilitating symptoms of nausea and epigastric pain in the gimoti treatment group achieved statistically significant relief In August 2018, evoke announced that the US FDA has accepted the listing application of gimoti In April last year, the US FDA rejected the drug's launch, noting that additional materials are needed to make up for the deficiencies in the application In December, evoke resubmitted its IPO application Today, the application was finally accepted "We are very pleased that the FDA has accepted the resubmission of gimoti's new drug application, and we look forward to working with the FDA throughout the review process," said Dave gonyer, President and CEO of evoke "We believe that there is an urgent need for medical staff and patients to have a new treatment plan to manage diabetic gastroparesis We are confident that gimoti can help meet this medical need and improve the quality of life of patients with this disease " reference material: [1] FDA Accepts Evoke Pharma’s NDA Resubmission for Gimoti Gamma PDUFA Target Goal Date is June 19, 2020，Retrieved January 21, 2020, from https:// [2] Evoke Pharma Official Website，Retrieved January 21, 2020, from https://evokepharma.com/product-focus/gimoti/ A kind of