The U.S. Food and Drug Administration (FDA) has approved a new form of a drug to treat gastroparesis, or delayed stomach emptying — a condition that’s often associated with diabetes. Gimoti (metoclopramide) by Evoke Pharma comes as a nasal spray, adding a new option for people who currently take metoclopramide tablets or receive the drug by injection.
In a normally functioning digestive system, rhythmic contractions of the stomach muscles break food down into smaller particles, which are then pushed into the small intestine to be broken down further. Gastroparesis happens when these muscle contractions don’t happen, or are weaker than they should be.
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In people with diabetes, gastroparesis is believed to be caused by a condition called diabetic autonomic neuropathy — damage to nerves that control the automatic functions of the body. One of these nerves, the vagus nerve, regulates digestion and helps ensure that the stomach muscles contracts as they should following a meal. Nerve damage in diabetes is caused by elevated blood glucose levels, which can damage many different kinds of cells throughout the body over time.
Common symptoms of gastroparesis include feeling full early when eating, heartburn, bloating, nausea and vomiting. The condition can be diagnosed through a number of different tests, some of which involve drinking a liquid or eating food containing barium, a substance that lets your doctor track the movement of the liquid or food in your digestive system using imaging scans such as X-rays.
While metoclopramide has been on the market since 1979, until now, it was available in only two forms: a tablet taken by mouth, and an injection. The oral form of the drug may be less than ideally effective in some people because in order to be absorbed, the drug needs to pass through the digestive system — which is slowed by gastroparesis. And injecting the drug brings its own difficulties, including fear of needles.
According to Evoke Pharma, taking the drug nasally works because because the nasal cavity contains a thin layer of mucous membrane, which allows metoclopramide to be easily absorbed directly into the bloodstream. And unlike some other drugs, metoclopramide doesn’t need to be metabolized by the liver in a “first pass” before reaching the areas of the body where it’s needed, which means that it works fairly quickly when taken nasally.
The company notes that unlike the oral form of metoclopramide, Gimoti is likely to be tolerated well even by people who are experiencing nausea and vomiting due to their gastroparesis. It may also be an option for people who tolerate the oral form of the drug, but are looking for a way to experience the drug’s effects more quickly.
“This approval represents the first novel pharmaceutical treatment for gastroparesis in several decades,” writes David Gonyer, RPh, President and CEO of Evoke Pharma, in a press release from the company. “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 healthcare providers and their patients a unique non-oral treatment option to relieve symptoms and help improve their quality of life.”
As noted in an article on the drug’s approval at Bezinga, Gimoti was initially rejected by the FDA. It’s not immediately clear what changed to allow its approval, but the FDA generally rejects drugs when it has concerns about safety or effectiveness compared to existing formulations of the drug, or other drugs that treat the same disorder.
The article notes that according to one pharmaceutical market analyst, annual sales of Gimoti are expected to peak at over $300 million by 2027. Evoke Pharma expects the drug to be commercially available throughout the United States by the fourth quarter of 2020.