New York Attorney General Letitia James has reached a settlement with Indivior, Inc., a multinational pharmaceutical company, to halt the misleading marketing of its opioid overdose drug Opvee (nalmefene) in New York. The state’s Department of Health (DOH) has not authorized Opvee for use without a prescription, yet Indivior promoted it as if it were interchangeable with Narcan (naloxone), which is widely recognized as the standard medication for reversing opioid overdoses.
Attorney General James stated, “Indivior cannot rewrite its history and exploit this drug crisis for profit. After playing a role in fueling the opioid epidemic, the company tried to position itself as part of the solution while misleading public officials and the communities they serve about which overdose treatments are safe, legal, and effective. Far too many families have lost loved ones to opioids and overdose, and my office will continue to do everything in its power to combat the devastating opioid crisis and keep New Yorkers safe.”
Health experts in New York emphasized that 4mg naloxone remains the most reliable opioid overdose reversal medication approved under the state’s standing order. Dr. James McDonald, Commissioner of DOH, said: “The deadly overdose epidemic continues to impact every community across New York state and fighting the epidemic includes equipping individuals, communities, organizations and agencies with the right tools. The most effective and reliable opioid overdose reversal medication on the market remains the 4mg naloxone, which is the only antagonist covered under the state’s standing order. The Department of Health remains committed to following the science and working with our dedicated state and local partners to save lives and end overdose deaths.”
Dr. Chinazo Cunningham from New York State Office of Addiction Services and Supports added: “Naloxone is the most effective way to reverse an overdose and has already saved the lives of thousands of New Yorkers impacted by opioid addiction… These actions by the Attorney General’s office will help keep more New Yorkers safe and ensure that naloxone remains the primary, trusted medication used in New York for opioid overdose reversal.”
Despite clear legal limitations on Opvee’s use outside prescription settings—especially among first responders—Indivior marketed it as a competitor to Narcan throughout dozens of counties in New York. An investigation found that Indivior advised at least one sheriff’s office that it could write its own standing order for Opvee after being told by DOH that such use was unauthorized; this led to an improper $22,500 purchase by that sheriff’s office.
Following these findings:
– Indivior must refund taxpayer money spent on improperly sold doses.
– All unused units must be returned.
– The company must cease making false statements about Opvee.
– Broad reforms are required for marketing practices targeting public agencies.
– Sales staff must accurately represent Opvee’s legal status.
– Sales of Opvee to public agencies are prohibited unless explicitly authorized by regulators.
Research indicates no evidence that Opvee is more effective than Narcan but shows it may cause longer-lasting withdrawal symptoms—up to 12 hours compared with Narcan’s typical 90 minutes—which can increase patient risk during recovery from an overdose.
In July 2024, Attorney General James secured an $86 million multistate settlement with Indivior related to its role in promoting products tied to addiction risk.
Attorney General James has also obtained over $3 billion through settlements from various companies involved in manufacturing or distributing opioids; funds support treatment, prevention efforts, abatement programs across New York State. She has led national coalitions resulting in significant financial settlements from pharmacies such as CVS https://www.ag.ny.gov/press-release/2022/attorney-general-james-secures-over-13-billion-opioid-crisis-cvs-and-walgreens, Walgreens https://www.ag.ny.gov/press-release/2022/attorney-general-james-secures-over-13-billion-opioid-crisis-cvs-and-walgreens, Walmart https://www.ag.ny.gov/press-release/2022/ag-james-delivers-more-funds-new-york-counties-combat-opioid-crisis, consulting firm McKinsey & Company https://ag.ny.gov/sites/default/files/mckinsey_multistate_agreement_1.pdf ,and marketing firm Publicis Health https://ag.ny.gov/sites/default/files/publicis_executed_settlement_agreement.pdf .
Several advocates expressed support for Attorney General James’ action against misleading promotion practices regarding unapproved medications like Opvee:
Laura Guzman (National Harm Reduction Coalition): “Naloxone works and saves lives… No company should be exploiting people to profit off the overdose epidemic.”
Dr.Kelly S. Ramsey (New York Society of Addiction Medicine): “We applaud…to stop Indivior’s aggressive marketing…while nalmefene products … carry additional risks.”
Alexis Pleus (Truth Pharm): “We appreciate … ensuring predatory practices … do not continue unchecked.”
Joyce Rivera (St. Ann’s Corner of Harm Reduction): “Let’s be clear: efforts … must be based on science … not dictated by corporate interests.”
Stephanie Marquesano (the harris project): “I am deeply grateful … for taking action … Every life saved is an opportunity for recovery…”
Ashley Livingston (Friends of Recovery Warren & Washington): “Holding companies accountable… sends a clear message…”
Ken Jenkins (Westchester County Executive): “Misleading marketing…endangers lives…. I commend Attorney General James…”
Mark C. Poloncarz (Erie County Executive): “It is important to hold pharmaceutical profiteers liable …”
Dr. Marielena Vélez de Brown (Monroe County Commissioner): “Misleading claims about alternatives put lives at risk …”
Senator Pete Harckham: “As we fight…the last thing we need is confusion caused by unapproved agents…”
The matter was handled within OAG divisions focused on health care oversight and law enforcement misconduct.
