FDA Approves Treatment for Recurrent Diabetes Gastroparesis

June 23, 2020

The first and only one of its kind, metoclopramide nasal spray offers relief to often debilitating symptoms of the gastrointestinal disease.

The FDA has approved metoclopramide (Gimoti, Evoke Pharma, Inc) nasal spray, which is the first and only nasally administered product for relief of acute and recurrent diabetes gastroparesis.

Individuals with gastroparesis experience a range of symptoms, including nausea, abdominal pain, bloating, early satiety, and vomiting, which can become debilitating. Evoke Pharma, which focuses on gastrointestinal (GI) disease treatments, will offer health care providers a non-oral treatment option for patients who often do not receive adequate relief.

Henry Parkman, MD, director of Gastroenterology Motility Laboratory, School of Medicine at Temple University, explained what gives the treatment its edge: “Unlike oral medications, Gimoti is administered nasally, bypassing the diseased GI track, allowing the drug to enter the bloodstream directly and therefore may provide predictable delivery of the therapy.”

The approval also provides Evoke with access to a line of credit totaling $5 million from EVERSANA to cover manufacturing and other costs of commercialization of metoclopramide nasal spray.

Safety information for metoclopramide includes that it can cause tardive dyskinesia, other extrapyramidal effects, parkinsonism symptoms, motor restlessness, and other adverse events.

“We are extremely pleased to have received FDA approval to commercially market GIMOTI in the United States. This approval represents the first novel pharmaceutical treatment for gastroparesis in several decades. Many times, patients do not experience adequate relief of their gastroparesis symptoms from current treatments, representing a significant need for a new approach to therapy. We are excited to be able to offer health care providers and their patients a unique non-oral treatment option to relieve symptoms and help improve their quality of life,” said David Gonyer, RPh, president and chief executive officer of Evoke Pharma, Inc.

Reference:

  1. FDA Approves Evoke’s GIMOTI. News Release. Evoke Pharma; June 19, 2020. Accessed June 23, 2020. https://evokepharmainc.gcs-web.com/news-releases/news-release-details/fda-approves-evokes-gimotitm.