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Auburn University pharmacy professor helps bring two new drugs to market

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Auburn University professor of pharmaceutics Bill Ravis has been instrumental in bringing two new drugs to market – Nesina® to treat type 2 diabetes and Impavido® to treat a parasitic disease that affects people in tropical and sub-tropical climates.  Ravis, in the Department of Drug Discovery and Development in the Harrison School of Pharmacy, collaborated with drug manufacturers on the studies and the FDA approval process.

Nesina is a peptidase-4 inhibitor used to treat type 2 diabetes, a disease that affects more than 29 million people in the United States.

In a project funded by Takeda Pharmaceuticals, Ravis served as a principal investigator to conduct the required FDA phase I studies on Nesina to examine the influence of kidney function and how this relates to how the body handles and reacts to the drug. Also investigated was dosing for the drug and its toxicity in diabetes patients. Ravis supervised the study with the assistance of the East Alabama Medical Center and Dr. Thomas Stokes.

Impavido is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis, a parasitic disease affecting more than 12 million people living in tropical and sub-tropical climates and also a concern for military personnel in these areas.

Ravis studied how the body absorbs, distributes, metabolizes and excretes the drug, along with how factors such as age, gender and lesion size affect the drug in the body. This information was required as part of the new drug application, which then was used to establish the dose regimens to improve the drug’s benefits and limit its adverse effects. Support for miltefosine, Impavido’s generic name, for drug development and the work at Auburn was coordinated by Fast Track Drugs and Biologics and sponsored by Paladin Therapeutics and the Department of Defense.

“It is exciting to be a part of the study and development for new drugs that become approved and can make an impact in people’s lives,” said Ravis. “Interactions and collaborations with the pharmaceutical industry not only are a source of research funding but also provide training, learning and career opportunities for our professional and graduate students in the drug development process. With the expertise and facilities, not only within the Harrison School of Pharmacy but across campus, collaborations with the pharmaceutical industry and Auburn have grown and will continue to grow more in the future.”

Ravis also has been involved in studies of other drugs. The results of a new intravenous product of carbamazepine for epilepsy and convulsions were presented as a “late-breaker” poster presentation at the 2014 Annual Meeting of the American Epilepsy Society. Ravis assisted in the pharmacokinetic analysis for the product which is due to be available next year from Lundbeck. The presentation was titled “Pharmacokinetic Evaluations of Oral and Intravenous Carbamazepine using a Model-Based Approach” and was authored by Auburn’s Ravis, Dwain Tolbert of Lundbeck and Aziz Karim with AzK Consulting.

For more information about Ravis and his research, go to http://www.auburn.edu/academic/pharmacy/directory/william-ravis.html. For more information about the Harrison School of Pharmacy, go to http://pharmacy.auburn.edu.

By Matt Crouch

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