Vince & Associates Clinical Research has been awarded a contract with the FDA Office of Generic Drugs (OGD) to conduct a clinical pharmacology pharmacokinetic (PK) study of opioids manipulated via milling procedures.
In the 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 the study is to evaluate factors that affect the bioavailability of milled opioid drug products following nasal snorting. The outcome of the study may help in determining critical study design parameters when comparing deterrence of nasal abuse between a generic and its Reference Listed Drug.
“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,” said Dr. Brad Vince, CEO and medical director at Vince & Associates Clinical Research.
The new deal does not mark the first time Vince & Associates has worked with the U.S. government on clinical research trials. In 2012, the company 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.