We have previously written about the Indivior settlement reached over allegations that the company was involved in the opioid epidemic. Just weeks before trial was scheduled to begin, Indivior announced settlement agreements with all plaintiffs involved in the multi-district litigation. As part of the agreement with the Claimants, Indivior agreed to pay $385 million and take a charge of $228 million in the third quarter of 2023, which will be excluded from the company’s adjusted earnings. Once approved by the United States District Court for the Eastern District of Pennsylvania, the case will officially be closed and likely in Indivior’s rearview mirror.
“We are pleased to achieve this settlement to conclude this legacy multi-district antitrust matter,” said Indivior Chief Executive Officer Mark Crossley. “The resolution of this litigation, which was filed over a decade ago, provides greater certainty for all Indivior stakeholders and allows us to continue focusing on our important work for patients suffering from opioid use disorder and mental health illnesses around the world.”
Indivior’s Checkered Past
This settlement does not represent the only hot water Indivior has been in surrounding Suboxone and its overall impact on the opioid epidemic. There was a 2021 settlement for $300 million regarding allegations that the company “falsely and aggressively” marketed Suboxone, an opioid addiction therapy drug, which led to the misuse of state Medicaid funds.
Additionally, Indivior agreed to pay $10 million to settle allegations by the Federal Trade Commission (FTC) that it violated antitrust laws through a deceptive scheme to thwart generic drug competition for Suboxone.
There was also a $600 million settlement in 2020 with federal and state authorities connected to Indivior’s former CEO pleading guilty to misleading the Massachusetts Medicaid program about the danger of Suboxone to children, in an attempt to secure formulary coverage. The settlement also prevented Indivior Solutions, the company’s opioid subsidiary, from participating in government health care programs.
…And Hopeful Future
However, the news for Indivior is not all bad. In May 2023, it received approval from the United States Food and Drug Administration (FDA) for its overdose rescue nasal spray, Opvee. Opvee is the first nalmefene hydrochloride nasal spray for the emergency treatment of known/suspected opioid overdose in adults and pediatric patients age 12 and older.
Opvee’s approval was supported by safety and pharmacokinetic studies, as well as a study in people who use opioids recreationally to assess how quickly the drug worked. The drug was granted Prior Review designation as it has the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition.