FDA accepts Vanda’s NDA for gastroparesis treatment (2024)

FAQs

What is the 2024 treatment for gastroparesis? ›

A PDUFA target date of September 18, 2024 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tradipitant for the treatment of gastroparesis. Tradipitant is an investigational oral neurokinin-1 receptor antagonist.

Metoclopramide: This medicine increases the movements in your digestive system, helping the food to pass through more quickly and efficiently. This is the only medication in the United States that is FDA approved to treat gastroparesis. However, in some patients it may cause movement disorders.

Tradipitant overview

Tradipitant (VLY-686, LY-686017) is under development for the treatment of gastroparesis, functional dyspepsia and motion sickness.

Nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen (Motrin, Advil), can help ease pain from gastroparesis. Many NSAIDs are available OTC.

Treatment is multimodal and includes dietary modification, prokinetic and anti-emetic medications, and surgical interventions. New advances in drug therapy, and gastric electrical stimulation techniques have been introduced and might provide new hope to patients with refractory gastroparesis.

Gastroparesis is a chronic condition, and in most cases, it does not go away or have a definitive cure. However, its symptoms can be managed, and the progression of the condition can be slowed with appropriate treatment.

Gastric peroral endoscopic myotomy (G-POEM) is a type of submucosal endoscopy or third space endoscopy that targets the pylorus muscle to treat gastroparesis. G-POEM was derived from peroral endoscopic myotomy (POEM), which targets the lower esophageal sphincter to treat achalasia.

One example is a new drug in development called Relamorelin. The results of a phase II trial found the drug could speed up gastric emptying and reduce vomiting. The drug is not yet approved in the United States by the Food and Drug Administration (FDA), but a larger clinical trial is currently underway.

Metoclopramide is currently the only medication that is US FDA approved for the treatment of gastroparesis [14].

What medications make gastroparesis worse? ›

Certain medications, such as opioid pain relievers, some antidepressants, and high blood pressure and allergy medications, can lead to slow gastric emptying and cause similar symptoms. For people who already have gastroparesis, these medications may make their condition worse.

Alternative therapies may provide relief to some people. These may include acupuncture, acupressure, biofeedback, hypnotherapy, the use of ginger, and skin application of antinausea medications.

Nutritional drinks are easy-to-digest liquids that can help with this. These include: yogurt smoothies. fruit and vegetable smoothies.

Compare brands and prioritize specific nutrients; for those with gastroparesis prioritize vitamin D, vitamin B12, calcium, and iron. Iron and calcium may not be found in the same supplement, you may need to consider several different types of supplements if you are concerned about vitamin deficiencies.

SmartPill is a disposable capsule that the patient swallows at their doctor's office. The capsule travels through the GI tract and wirelessly transmits data about the GI tract to a recorder worn on a belt clip or lanyard.

For some people, gastroparesis affects the quality of their life, but is not life-threatening. They might be unable to complete certain activities or work during flare-ups. Others, however, face potentially deadly complications.