FDA Approves Glycopyrrolate Orally Disintegrating Tablets for Peptic Ulcer Treatment

Officials with the FDA have approved glycopyrrolate orally disintegrating tablets (Dartisla ODT; Edenbridge Pharmaceuticals) to reduce the symptoms of a peptic ulcer and as an adjunct to treatment of peptic ulcers.¹

According to a press release, the 1.7 mg orally disintegrating tablets (ODTs) are the first and only ODT form of glycopyrrolate. The product will be launched in early 2022.¹

“We are thrilled to receive approval for Dartisla ODT, which will provide physicians and patients with a novel treatment option,” said Daniel G. Worley Jr, PharmD, Esq, vice president of business development and associate general counsel for Edenbridge, in the press release.¹

Peptic ulcers can be caused by long-term use of nonsteroidal anti-inflammatory drugs, an infection with Helicobacter pylori, or by rare cancerous and noncancerous stomach tumors. Common symptoms include a dull or burning pain in the stomach, most often when the stomach is empty. Less common symptoms can include bloating, burping, nausea, lack of appetite, vomiting, or weight loss.²

Patients receiving the 2 mg dosage strength of another oral tablet form of glycopyrrolate can be switched to the 1.7 mg dosage strength of glycopyrrolate ODT. It is not recommended for patients who are initiating treatment or receiving maintenance treatment with a lower dosage strength of another oral glycopyrrolate product.¹

Adverse events in clinical trials included blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention.¹ Patients at risk for anticholinergic toxicity due to underlying medical conditions or who have hypersensitivity to glycopyrrolate should not take glycopyrrolate ODT.

REFERENCES

1. Edenbridge Pharmaceuticals Announces US FDA Approval of Dartisla ODT (Glycopyrrolate) Orally Disintegrating Tablets. News release. BusinessWire; December 17, 2021. Accessed December 20, 2021. https://www.businesswire.com/news/home/20211217005400/en
2. National Institute of Diabetes and Digestive and Kidney Diseases. Symptoms & Causes of Peptic Ulcers (Stomach Ulcers); Reviewed November 2014. Accessed December 20, 2021. https://www.niddk.nih.gov/health-information/digestive-diseases/peptic-ulcers-stomach-ulcers/symptoms-causes