FDA and Optivia Collaborate on Dietary Supplements

The research collaboration will assess the ability of various dietary supplements, including black cohosh, green tea, ginko biloba, kava, usnic acid and potentially others, to affect various drug transporters.

2/4/2011 --- Optivia Biotechnology Inc., a leading provider of in vitro transporter assay services, announced that the company and the U.S. Food and Drug Administration (FDA) have signed a collaboration agreement to assess the effect of dietary supplements on key drug transporters. The goal of the collaboration is to identify potentially harmful drug-dietary supplement interactions, such as an interaction with acetaminophen and other drugs associated with liver toxicity.

The importance of drug transporters to drug safety is gaining increased attention, aided by a recent report from the International Transporter Consortium (“Membrane Transporters in Drug Development,” Nature Reviews-Drug Discovery, March 2010), which identified the most clinically significant transporter-related drug-drug interactions.

The research collaboration will assess the ability of various dietary supplements, including black cohosh, green tea, ginko biloba, kava, usnic acid and potentially others, to affect various drug transporters. As a starting point, the seven transporters cited by the International Transporter Consortium and the FDA as the most clinically relevant to transporter-related drug-drug interactions will be examined using Optivia’s transporter technology platform. This novel platform features polarized mammalian cell assays that closely model human biology. Optivia and the FDA will then analyze and interpret the drug transporter data as preparation for publishing the results.

“This project further advances Optivia’s leadership position in the development of quantitative tools for optimizing the safety and efficacy of drugs,” stated Yong Huang, Ph.D., president and chief executive officer of Optivia Biotechnology. “We are excited about this opportunity to expand the use of our technology to examine the role of dietary supplements in causing drug-related liver injury.”

Drug-induced liver toxicity is estimated to be responsible for as many as five percent of all hospital admissions and 50 percent of all acute liver failures. It is well established that transporters greatly influence the disposition by the liver of a number of commonly used drugs (e.g. antibiotics, statins, and hypoglycemic agents) and others that were subsequently removed from the market (e.g. the antidepressant nefazodone).