Edenbridge Pharmaceuticals Announces the Launch of DARTISLA ODT

Rhea-AI Summary

DARTISLA ODT, the first FDA-approved orally disintegrating tablet of glycopyrrolate, is now available in the U.S. for adults to treat peptic ulcers. The product is accessible through prescription via Phil and retail pharmacies. Edenbridge Pharmaceuticals sponsors a Copay Program that enables eligible patients to acquire the medication for as little as $0. This innovative tablet is manufactured by Catalent using proprietary technology, allowing quick dissolution without water. The FDA approved this product on December 16, 2021.

Positive

• DARTISLA ODT is the first and only FDA-approved orally disintegrating tablet formulation of glycopyrrolate.
• The launch includes a Copay Program allowing eligible patients to obtain DARTISLA ODT for as little as $0.

Negative

• Adverse reactions reported include drowsiness, dry mouth, and urinary retention, which could limit patient acceptance.

DARTISLA ODT is available as a 1.7 mg orally disintegrating tablet and is indicated for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer

First and only orally disintegrating tablet (ODT) of glycopyrrolate

DARTISLA ODT Copay Program ensures broad patient access

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Edenbridge Pharmaceuticals, LLC (“Edenbridge”) today announced that DARTISLA ODT (glycopyrrolate) is now available by prescription in the United States through Phil, the commercialization partner and eHub for DARTISLA ODT, as well as in retail pharmacies throughout the country. To ensure access to patients in need, Edenbridge is sponsoring the DARTISLA ODT Copay Program, which allows eligible patients to obtain the product for as little as $0 when filled through Phil or $20 when filled at other pharmacies.

“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 healthcare providers,” noted Daniel G. Worley Jr., Edenbridge’s Vice President of Business Development and General Counsel. “Further, Edenbridge is committed to ensuring patient access to this product, and we are pleased to be sponsoring the DARTISLA ODT Copay Program to facilitate getting DARTISLA ODT into the hands of people that need it most.”

“Phil is proud to support Edenbridge’s commitment to providing broad access to this innovative therapy by simplifying the patient onboarding process allowing affordable, fast, broad-based distribution of Dartisla ODT,” said Deepak Thomas, Founder and CEO of Phil.

The U.S. Food and Drug Administration (FDA) approved Dartisla ODT for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer on December 16, 2021. DARTISLA ODT is manufactured by Catalent (NYSE: CTLT) using their proprietary Zydis^® orally disintegrating tablet delivery technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water.

For more information on the DARTISLA ODT Copay Program and available savings offers, visit www.dartisla.com/copay-card.

Patients receiving the 2 mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 1.7 mg dosage strength of DARTISLA ODT. DARTISLA ODT is not recommended for patients initiating treatment or receiving maintenance treatment with a lower dosage strength of another oral glycopyrrolate product (e.g., tablet strength of 1 mg). Patients who are at risk for anticholinergic toxicity due to various underlying medical conditions or who have hypersensitivity to glycopyrrolate or the inactive ingredients should not take DARTISLA ODT. Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. Please visit www.dartisla.com and consult the full prescribing information for additional important information.

About Edenbridge

Edenbridge is a specialty pharmaceutical company focused on identifying, developing, and marketing prescription pharmaceutical products. Edenbridge’s goal is to create a broad portfolio of limited source branded and generic pharmaceutical products that will provide high-quality, affordable, and accessible alternatives in the healthcare market. Edenbridge’s approach is to work with best-in-class and like-minded industry partners to deliver its products to physicians and patients everywhere. Founded in 2008, Edenbridge launched its first product in February 2010 and has sold its commercial products through every major channel of the U.S. prescription pharmaceutical supply chain. In addition, Edenbridge has a robust product development pipeline that includes 505(b)(2) NDAs, ANDAs, and foreign filings. For more information, visit www.edenbridgepharma.com or contact the Company directly at info@edenbridgepharma.com.

About Phil

Phil is a commercialization partner for innovative life sciences companies, offering pharmaceutical manufacturers a modern alternative to traditional access, affordability and distribution options. Through its digital stakeholder experiences, patient access services, market access solutions and distribution models, pharma manufacturers can provide patients with more affordable and timely therapy access. For more information on Phil, visit phil.us.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220228005675/en/

Edenbridge Contact

Daniel G. Worley Jr.

Vice President, Business Development & General Counsel

201-479-1336

dworley@edenbridgepharma.com

Source: Edenbridge Pharmaceuticals, LLC

FAQ

What is DARTISLA ODT and its indication?

DARTISLA ODT is an orally disintegrating tablet of glycopyrrolate approved for adults to reduce symptoms of a peptic ulcer.

When was DARTISLA ODT approved by the FDA?

DARTISLA ODT was approved by the FDA on December 16, 2021.

Who manufactures DARTISLA ODT?

DARTISLA ODT is manufactured by Catalent.

How much can patients pay for DARTISLA ODT through the Copay Program?

Eligible patients may obtain DARTISLA ODT for as little as $0 through the Copay Program.

Where can DARTISLA ODT be purchased?

DARTISLA ODT can be acquired through Phil or retail pharmacies across the United States.