Researchers at Washington University School of Medicine in St. Louis are studying the quality, effectiveness and safety of generic drugs used to treat depression.
The research is supported by the U.S. Food and Drug Administration (FDA) and is the only study of its kind funded by the agency. The study will determine whether brand-name 300 mg bupropion hydrochloride (HCl) extended-release (ER) tablets sold commercially as Wellbutrin XL and the various generic versions of bupropion HCl ER tablets work the same in the body and deliver the same therapeutic benefits.
The principal investigator is Evan D. Kharasch, MD, PhD, the Russell D. and Mary B. Shelden Professor of Anesthesiology and an expert in clinical pharmacology, drug metabolism, drug interactions, mechanisms of drug toxicity and pharmacogenetics, a clinical pursuit that focuses on understanding the ways that individuals can respond to the same drug differently.
"Since generic versions of extended-release bupropion HCl were introduced, there have been some reports that they may not be as effective as the brand-name drug and may be associated with adverse events," Kharasch said. "The first time a 300 mg generic version of this drug was tested, there were significant differences in drug concentrations in the blood compared with what was seen with the brand-name drug, Wellbutrin XL, and that generic formulation eventually was taken off the market. Now, we're going to study several generics to evaluate their blood concentrations in patients, how effective they are, and whether they are associated with side effects or with relapse. This study will go beyond the tests that have been conducted previously."
Kharasch, an anesthesiologist at Barnes-Jewish Hospital and also vice chancellor for research at Washington University, is collaborating with Eric Lenze, MD, professor of psychiatry. They will study blood samples from patients with depression to learn how much of the ge
|Contact: Jim Dryden|
Washington University School of Medicine