Eurand's AdvaTab Cetirizine Successfully Meets Major Development Milestone

Main Category: Allergy
Also Included In: Clinical Trials / Drug Trials
Article Date: 16 Mar 2006 - 0:00 PDT

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Eurand, a specialty pharmaceutical company, today reported the achievement of a major milestone in the development program for its AdvaTab(R) formulation of cetirizine, a leading prescription antihistamine sold in the United States and other markets as Zyrtec(R). AdvaTab Cetirizine is a taste-masked, stabilized formulation that utilizes Eurand's proprietary Microcaps tastemasking and AdvaTab orally disintegrating tablet (ODT) technologies. The AdvaTab technology produces tablets that disintegrate rapidly in the mouth and can be taken with or without water.

In a pharmacokinetic study, Eurand's AdvaTab Cetirizine was determined to be bioequivalent to immediate release cetirizine tablets, and to have superior organoleptic properties in terms of taste and texture.

Eurand expects to complete the development program by end of 2006 and will pursue regulatory submissions for the product thereafter.

"We are pleased to have reached this development milestone, which further validates Eurand's AdvaTab technology," commented Gearoid Faherty, Eurand's CEO. "AdvaTab Cetirizine is an important additional dosing option for patients that may benefit from the convenience offered by AdvaTab. Our combined ODT and tastemasking technology platforms provide us and our partners with significant product development opportunities and we look forward to the commercialization of this product and others in our product pipeline."

Study Design

The study was designed to evaluate the pharmacokinetic profile and organoleptic (sensory) properties of AdvaTab Cetirizine (10mg) compared with those of Zyrtec (10mg) immediate release tablets and Zyrtec (10mg) chewable tablets under fed conditions. The study was conducted using 16 healthy volunteers. In a 4-way crossover study design, plasma profiles of cetirizine were determined for each volunteer following administration of a Zyrtec chewable tablet without water, a Zyrtec immediate release tablet with water and an AdvaTab Cetirizine tablet taken both with and without water. Plasma levels of cetirizine were measured over a 24 hour period. In addition, the organoleptic properties of the AdvaTab product were assessed in the trial. AdvaTab Cetirizine was determined to be bioequivalent to both immediate release and chewable immediate release tablets in all conditions tested.

Eurand expects to enter into agreements with strategic partners for the marketing and distribution of the product in the U.S., Europe and other countries throughout the world. Subject to regulatory approvals, Eurand anticipates that it will manufacture and supply its partners' commercial requirements for the product.

Cetirizine

Cetirizine is approved for the relief of indoor and outdoor allergy symptoms. Pfizer promotes the immediate release products in the United States as Zyrtec tablets and Zyrtec Chewable tablets. The product is promoted in Europe by UCB. Sales of Zyrtec in the United States were approximately $1.36 billion in 2005(1).

AdvaTab

AdvaTab can provide physicians and patients with additional dosing options for patients that can benefit from convenience in dosing such as those that have difficulties in swallowing or patients who may not have ready access to water. AdvaTab can be a suitable dosage form for pediatric patients. Studies estimate that approximately 40% of the American population has experienced problems swallowing tablets.

The AdvaTab technology produces tablets that disintegrate rapidly in the mouth and can be taken with and without water. AdvaTab tablets are comprised of drug particles that may be tastemasked using Eurand's Microcaps technology and that are designed for either immediate or controlled drug release. The tablets can be packaged in either bottle or blister packs.

Eurand

Eurand is a privately held specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug delivery technologies. The Company specializes in four areas: bioavailability enhancement of poorly soluble drugs, customized release, taste masking/fast-dissolving formulations, and drug targeting. Eurand has had three products approved by the FDA since 2000 and is currently developing a pipeline of products based on its proprietary drug delivery technologies. The company also works with many of the world's leading pharmaceutical and biotechnology companies to develop enhanced forms of their existing products and development compounds.

Eurand is a global company with more than 500 employees and annual revenue of more than $100 million. Eurand is based in Milan, Italy, with research, development and manufacturing facilities throughout the world, including sites in Milan, Italy; Vandalia, Ohio (US) and Paris, France. Eurand has partnered with Warburg Pincus, one of the world's leading private equity firms. For more information, visit Eurand's website at http://www.eurand.com.

Eurand
http://www.eurand.com