Edenbridge announced the availability of Dartisla ODT, an orally disintegrating tablet formulation of glycopyrrolate, to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.

Dartisla ODT received approval from the Food and Drug Administration (FDA) in December 2021 through the Agency’s 505(b)2 pathway, which allows for some of the information required for approval to come from studies not conducted by the applicant. 

Each tablet of Dartisla ODT contains 1.7mg of glycopyrrolate, an anticholinergic agent.  Following administration of Dartisla ODT, the Cmax and AUC were found to be comparable to an oral 2mg glycopyrrolate tablet. Patients receiving the 2mg dosage strength of another oral tablet form of glycopyrrolate may therefore be switched to Dartisla ODT 1.7mg.

Dartisla ODT is not recommended for initial or maintenance treatment of patients who require a lower dosage strength of glycopyrrolate (eg, 1mg tablet strength). The treatment is also not indicated for monotherapy as its effectiveness in peptic ulcer healing has not been established.

The most common adverse reactions associated with therapy include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. Dartisla ODT is contraindicated in patients at risk for anticholinergic toxicity due to various underlying medical conditions.

“Dartisla ODT is the first and only FDA-approved orally disintegrating tablet of glycopyrrolate, and we are excited to introduce this novel formulation of glycopyrrolate to patients and health care providers,” said Daniel G. Worley Jr, Edenbridge’s Vice President of Business Development and General Counsel.

The Company has also launched a copay savings program.

References

  1. Edenbridge Pharmaceuticals announces the launch of Dartisla ODT. News release. February 28, 2022. https://www.businesswire.com/news/home/20220228005675/en/Edenbridge-Pharmaceuticals-Announces-the-Launch-of-DARTISLA-ODT
  2. Dartisla ODT. Package insert. Edenbridge Pharmaceuticals, LLC. Accessed February 28, 2022. http://www.dartisla.com/downloads/Dartisla-pi.pdf