Versatab is a multilayered tablet that can contain up to three active pharmaceutical ingredients (APIs), eliminate non-linear delivery profiles and improve compliance by reducing tablet intake.
IntelGenx is now beginning scale up and manufacture of the product, called INT001, with the pivotal bioequivalence study anticipated to take place in Q3 and an abbreviated new drug application (ANDA) filed in Q4.
Horst Zerbe, President and CEO of IntelGenx, said: “Once again our scientists, our technology and our expertise have proven to be successful. We were confident going into this clinical study and 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.”
The product is the result of a partnership between IntelGenx and DAVA that the companies entered into in March 2008. Under the terms of the agreement IntelGenx is developing the product and DAVA will be responsible for US commercialisation and marketing activities.
Versatab delivery tech
INT001 has been developed using IntelGenx’ Versatab drug delivery formulation, which the company developed to improve on existing controlled-release tablets.
IntelGenx claims that its tablets can be formulated to have a linear delivery profile, unlike single layer tablets, because the API can be sandwiched between two excipient layers that erode over time.