New GERD, gastroparesis treatment uses fast-dissolve technology
November 4th, 2009 by Jennifer Walker-Journey
Salix Pharmaceuticals’ new gastrointestinal disorder treatment Metozolv (metoclopramide) OTC (orally disintegrating tablet ) utilizes Zydis, a fast-dissolve technology made by Catalent Pharam Solutions. Zydis is a unique, freeze-dried oral solid dosage form that can be swallowed without water because it dissolves instantly on the tongue in less than three seconds, according to Catalent. This delivery method translates to dosing convenience and ease of administration that makes taking medication easier for patients.
Marketing for Metozolv was approved last September by the Food and Drug Administration (FDA) for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy. It also is the first orally disintegrating tablet formulation for both acute and recurrent diabetic gastroparesis.
“We are very proud to achieve the FDA approval of Metozolv ODT,” said Eugene T. Haley, CEO of Wilmington Pharmaceuticals, developers of Metozolv. “We’re especially pleased that the application of Catalent’s Zydis technology to this proven medication may enhance the lives of patients for years to come. Metozolv’s success further validates the commercial attractiveness of fast-dissolving dosage forms and illustrates the significant inherent value in bringing together a game-changing drug delivery technology with product development expertise and a top notch sales and marketing organization.”
While approved by the FDA, Metozolv carries the same black box warning as other metoclopramide products, such as Reglan. The medication fell under the warning earlier this year after numerous reports of a serious movement disorder known as Tardive Dyskinesia were linked to long-term use of metoclopramide.
Source: Reuters