Abbott Study Shows Investigational Heat-Stable Norvir® Tablet Provides Similar Drug Levels to Current Norvir Capsule
Pivotal Study of Norvir Tablet Bioavailability Will Form the Basis of Request for Priority Regulatory Review
Abbott presented pivotal data at the XVII International AIDS Conference (AIDS 2008) in Mexico City today showing that its investigational Norvir® (ritonavir) tablet and the current soft-gelatin capsule provide similar levels of drug in the blood.
The heat-stable Norvir tablet will not require refrigeration, making it more convenient for patients to use, particularly in developing countries where the majority of people with HIV live.
The heat-stable formulation of ritonavir may help to further expand protease inhibitor-based HAART (highly active antiretroviral therapy) in regions where the need for refrigeration of HIV medicines is a major barrier to treatment and care" said Pedro Cahn, M.D., Ph.D., president, International AIDS Society.
The study compared the bioavailability of the 100mg ritonavir tablet to that of a 100mg soft-gelatin capsule under non-fasting conditions. The ritonavir tablet demonstrated similar bioavailability to the current soft-gelatin capsule, and was generally well tolerated. In this study performed in 93 healthy adult volunteers, the safety profiles of the two formulations were similar, with no serious adverse events reported.
Several formulations were evaluated, and the final formulation evaluated in the bioavailability study is the product of significant testing and formulation work. The data presented are the basis of upcoming regulatory submissions.
Abbott has confirmed its intention to submit registration applications for the tablet and request priority review by US and EU authorities before the end of the year.
-Abbott intends to register the new Norvir tablet as broadly worldwide as lopinavir/ritonavir, the most widely registered PI worldwide, according to the World Health Organization. The lopinavir/ritonavir tablet is approved for sale, available (in countries where no regulatory approval is needed), or has been submitted for registration in 157 countries around the world.
The Norvir tablet was developed using the Meltrex® technology, which was also used in the development of Abbott’s Kaletra® tablets, which combine ritonavir and lopinavir. However, ritonavir on its own required a different formulation to ensure that the tablets remain stable over time and that the body can absorb the drug.
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