Maker of Suboxone Film Hit with Federal Fraud Indictment

The maker of the Suboxone film formulation of buprenorphine for the treatment of opioid dependence has been indicted on 28 counts of fraud and conspiracy, accused of using deceptive tactics to convince prescribers and insurers that its drug was safer than other buprenorphine versions.

The indictment that was announced April 9 against British company Indivior was filed in federal court in Virginia, and involves prosecutors' claims that the company fraudulently obtained billions in health care payments as many providers transitioned from prescribing sublingual Suboxone (buprenorphine with naloxone) tablets to Suboxone film. The company has vigorously denied the allegations.

Heavy promotion of Suboxone film occurred at a time when the period of market exclusivity for Suboxone tablets was expiring and the emergence of generic versions of buprenorphine plus naloxone was threatening the brand-name manufacturer's market share.

According to news reports, the indictment alleges that the illegal behavior started before former Suboxone maker Reckitt Benckiser spun off its prescription drug business to Indivior in 2014. An arraignment in the federal case is scheduled for next month, with Indivior accused of multiple counts of health care fraud, mail fraud and wire fraud.

The indictment alleges that Indivior characterized the sublingual film as less prone to diversion and abuse, when it actually knew that the sublingual formulation brought higher risks, including greater potential exposure to children.

A physician who offers buprenorphine and related services for opioid addiction in the Rhode Island outpatient practice Medical Assisted Recovery tells Addiction Professional that he never believed the film version was less prone to abuse, although he did believe it would be associated with fewer accidental poisonings in children. “I do know that it is far superior to the tablets in patient satisfaction,” says Sylvester Sviokla, MD. “It is especially good when bringing the patients down to a lower dose.”

The government is seeking at least $3 billion in penalties against the company. Indivior reportedly had been in discussions with the Department of Justice about a resolution of the matter, but an agreement did not come to fruition.

Indivior also has been engaged in legal battles with several companies that have sought to introduce generic versions of Suboxone film to the U.S. market.