Avridi Overdose Problems Raise Concerns Among FDA Reviewers

Federal drug reviewers are concerned that a proposed new painkiller, Avridi, could pose an overdose risk because food intake may interfere with its painkilling effects. 

FDA investigators released a report (PDF) ahead of a September 10 FDA advisory board meeting, which warns that Purdue Pharma’s proposed fast-acting oxycodone painkiller could lead to overdosing among patients who eat close to the time the pill is taken.

The reviewers indicate that the pill needs to be taken on an empty stomach, but history suggests that many users are not used to following food directions when using opioids. This may result in the painkiller not working effectively, potentially leading to dosing problems.

An independent committee of FDA advisors are scheduled to meet on Thursday to review the drug’s safety and effectiveness, and will then recommend to the agency whether the drug should be approved for sale. The advisory board’s recommendations are not binding on the FDA, but their votes usually factor heavily into the agency’s final decisions on new drugs.

In the report prepared for the advisory committee, FDA staff reviewers expressed concern that users would eat soon before or after taking the pill, feel no effects from the medication and potentially take another dose to increase the pain killing effects, thus increasing their risk of overdose and addiction.

“The abuse of prescription opioid products is a growing public health problem in the United States, but it is of great importance to maintain the availability of opioid analgesics for the millions of patients in this country who suffer from pain,” the FDA reviewers wrote. “FDA has encouraged drug companies to develop opioid analgesics with properties intended to deter their abuse.”

Purdue has suggested that the drug carry label warnings indicating that it is to be taken on an empty stomach, and that users should wait 4-6 hours between doses. However, the reviewers doubt the label warnings would be effective.

“Opioid analgesics are generally taken without regard to food, and it is not clear whether labeling would be sufficient to change long-standing behaviors of both prescribers and patients,” the review indicates. “All of these issues may result in patients taking Avridi without regard to food, leading to variability in systemic exposure to oxycodone, variable or delayed efficacy, and the possibility of taking extra doses that could lead to serious adverse events.”

Painkiller Abuse, Overdoses, At “Epidemic” Levels

According to the findings of a recent report by the Robert Wood Johnson Foundation and Trust for America’s Health, nearly 44,000 drug overdose deaths occur each year, with half of those linked to prescription drugs. West Virginia was the state with the most drug overdose deaths, with 33.5 per every 100,000 residents.

The report indicates that more than two million people in the U.S. abuse prescription drugs, and that abuse has fueled a resurgence in the popularity of heroin. The drug overdose death rates have been on the rise for four years in 26 states and the District of Columbia. In only six states have the rates gone down.

In 2012, the U.S. Centers for Disease Control and Prevention (CDC) released a report which indicated prescription drug overdoses have reached epidemic proportions. Prescription drug overdoses kill someone in the U.S every 19 minutes.

Overdoses, intentional and unintentional, by painkillers have driven death rates to numbers higher than those of cocaine and heroin combined since 2003.

In April, the FDA issued final guidance on opioid painkillers with abuse-deterrent properties. The guidance focuses on bringing new abuse-deterrent drugs to market quickly, while balancing access to opioid painkillers and reducing misuse and abuse.