PDUFA Fee Waived for Gastroparesis Treatment

According to a story from Financial Buzz, the pharmaceutical company Evoke Pharma announced that the U.S. Food and Drug Administration has approved a small business waiver for Gimoti, a nasally delivered treatment for women with gastroparesis. Without the waiver, the company would have had to pay a $2.4 million fee for its New Drug Application. The fee is mandated under the Prescription Drug User Fee Act. The active ingredient in Gimoti is metoclopramide.

Gastroparesis, also known as delayed gastric emptying, is a medical condition in which the stomach becomes partially paralyzed. As a result, the contents of the stomach remain there for an unusually long period of time. The vagus nerve is responsible for stomach contractions that move stomach contents into the small intestine for digestion. Often, this nerve has sustained damage when gastroparesis occurs. Symptoms of the condition include nausea, vomiting of undigested food, abdominal pain, and a feeling of fullness after only a couple of bites of food. Longer term problems include body aches, heartburn, appetite and weight loss, changes to blood glucose levels, bloating, and morning nausea. Undigested food can also be a breeding ground for infectious bacteria and it can also block the digestive tract. It is a complication that occurs in a variety of other illnesses. To learn more about gastroparesis, click here.

The waiver is a benefit to the company because it will allow them to focus more on finalizing the application for Gimoti. Evoke Pharma specializes in developing treatments that are meant to treat a variety of medical problems associated with the stomach and the intestinal tract. Currently, metoclopramide is the only drug that has currently obtained approval for the treatment of gastroparesis in the U.S. Gimoti is meant to increase effectiveness by offering a new method of administration. Currently, metoclopramide is orally or via intravenous injection.

Meticlopramide can treat gastroparesis because it increases resting muscle tone and increases contractility in the stomach. As a dopamine receptor antagonist, the medication can also stop nausea and vomiting. Hopefully, Evoke Pharma’s innovative formulation will allow more women suffering from gastroparesis to find relief once its New Drug Application has been approved.


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