The results of the study indicate that the product is bioequivalent to a leading antihypertensive product brand. The product has been developed using IntelGenx’s multilayer ‘Versatab’ delivery technology. Versatab provides a patent-protected, cost-effective method of formulating up to three active ingredients in a single dosage form.
Scale-up and manufacturing of the pivotal batches will now commence. In addition, it is anticipated that the pivotal bioequivalence study for the product will be conducted later in 2009. If the results of the study are satisfactory, it would be followed by the submission of an abbreviated new drug application to the FDA.
Horst Zerbe, president and CEO of IntelGenx, said: “We are delighted with these results. This is a significant achievement for IntelGenx that reaffirms our technological capabilities. We are now eager to move forward to the next level of pivotal clinical studies with our partner Dava Pharmaceuticals.”