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news.Vince & Associates Clinical Research has been awarded a contract with the US Food and Drug Administration (FDA) Office of Generic Drugs (OGD) to conduct a clinical pharmacology pharmacokinetic (PK) study of opioids manipulated via milling procedures.
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In this study-specific contract, Vince & Associates is responsible for conducting the opioid PK study and providing the necessary support services including study design, protocol development, clinical operations, data management, biostatistics, bioanalytical analysis and medical writing.
The objective of this study is to evaluate factors that affect the bioavailability of milled opioid drug products following nasal snorting. The outcome of this study may help in determining critical study design parameters when comparing deterrence of nasal abuse between a generic and its Reference Listed Drug.
Vince & Associates Clinical Research CEO and medical director Brad Vince said: "We are eager to partner with the FDA to help address agency concerns about the manipulation of opioid products. Vince & Associates is uniquely qualified to conduct this trial as our Principal Investigators have extensive substance abuse clinical knowledge and are industry leaders in the conduct of substance abuse trials."
"This type of study is ideally suited to the technical capabilities of Vince & Associates Clinical Research. Our state-of-the-art pharmacy with facial recognition security is equipped with a biosafety hood preparation area and controlled substance storage, which are essential for completing complex clinical studies involving opioids," stated Dr. Lorraine M. Rusch, Vice President, Scientific Development.
This is not the first time Vince & Associates has worked with the U.S. Government on clinical research trials. In 2012, Vince & Associates was awarded a five year, $10 million contract with the National Institute on Drug Abuse as well as a separate five year, $5 million contract with the FDA.
The project described in this press release was supported by FDA-RFP-1155964. The content above is solely the responsibility of the authors and does not necessarily represent the official views of the FDA.