The Food and Drug Administration (FDA) has approved Dartisla ODT (glycopyrrolate) in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.

Dartisla ODT is an anticholinergic drug that contains 1.7mg of glycopyrrolate in each orally disintegrating tablet. The treatment is not indicated as monotherapy for treatment of peptic ulcer because the effectiveness in peptic ulcer healing has not been established. 

Patients receiving the 2mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 1.7mg dosage strength of Dartisla ODT. It is not recommended for patients in whom a lower dosage strength of another oral glycopyrrolate product (e.g., tablet strength of 1 mg) is appropriate for initial or maintenance treatment. 

The application was submitted under the FDA’s 505(b)(2) approval pathway; this regulatory route allows the applicant to submit information from studies conducted by a separate entity and for which the applicant has not obtained a right of reference. The adverse reactions associated with the use of glycopyrrolate include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. 

Dartisla ODT is supplied as 1.7mg glycopyrrolate orally disintegrating tablets in 30-count cartons, and is expected to be available in early 2022.

“We are thrilled to receive approval for Dartisla ODT, which will provide physicians and patients with a novel treatment option,” remarked Daniel G. Worley Jr., Edenbridge’s Vice President of Business Development and Associate General Counsel. “This marks a major milestone for Edenbridge as our first 505(b)(2) NDA to receive approval from the FDA. We look forward to this new chapter for our company as we continue our strategic expansion into branded specialty prescription products.”

References

  1. Edenbridge Pharmaceuticals announces US FDA approval of Dartisla ODT (glycopyrrolate) orally disintegrating tablets. News release. Edenbridge Pharmaceuticals, LLC. Accessed December 17, 2021. https://www.businesswire.com/news/home/20211217005400/en/Edenbridge-Pharmaceuticals-Announces-U.S.-FDA-Approval-of-DARTISLA-ODT-Glycopyrrolate-Orally-Disintegrating-Tablets
  2. Dartisla ODT. Package insert. Edenbridge Pharmaceuticals, LLC; 2021. Accessed December 17, 2021. http://www.dartisla.com/downloads/Dartisla-pi.pdf.