Attorney General James Stops Misleading Marketing of Unauthorized Opioid Overdose Drug

NEW YORK – New York Attorney General Letitia James today announced a settlement with Indivior, Inc. (Indivior), a multinational pharmaceutical company, stopping the company’s misleading promotion of its opioid overdose drug, Opvee (generic name nalmefene). Despite knowing Opvee is not authorized by the New York State Department of Health (DOH) for use without a prescription, Indivior marketed the drug to public officials throughout the state and promoted its availability as if it were interchangeable with Narcan (generic name naloxone), the gold-standard medication for overdose reversals. Health officials and advocates in New York and nationwide have warned against substituting Opvee for Narcan, citing the drugs’ similar effectiveness and Opvee’s significantly more severe side effects. As part of its agreement with the Office of the Attorney General (OAG), Indivior must refund taxpayer dollars it was paid for Opvee, recall improperly sold doses, stop making false statements about Opvee, and implement broad reforms to its marketing and training practices. Two days after signing the agreement, Indivior informed stakeholders that it would discontinue promotion of Opvee altogether.

“Indivior cannot rewrite its history and exploit this drug crisis for profit,” said Attorney General James. “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.”

“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,” said New York State Department of Health Commissioner Dr. James McDonald. “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.”

“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,” said New York State Office of Addiction Services and Supports Commissioner Dr. Chinazo Cunningham. “At a time when we are beginning to see overdose deaths decline, it is critical that we remain consistent in our messaging. To date, we have provided more than 355,000 naloxone kits free of charge through our online ordering portal. 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.”

Indivior, which previously reached an $86 million settlement with Attorney General James and a coalition of other states for its role in the opioid epidemic, has presented Opvee as a better alternative to Narcan. Unlike Narcan, however, Opvee has not been authorized by DOH for use in overdose prevention programs that rely on non-medical personnel such as police officers, first responders, or community health workers. Despite this clear limitation under state law, Indivior marketed and sold the drug as if it were a viable competitor to Narcan, misleading public agencies and undermining established, evidence-based overdose prevention efforts. 

The OAG investigation found that Indivior’s representatives promoted Opvee to county administrators, commissioners, sheriffs, public and mental health officers, and EMS chiefs in dozens of counties throughout New York. In 2024, one such sheriff’s office asked DOH if it could use Opvee instead of Narcan. DOH responded that Opvee was an unauthorized medication and followed up with written guidance explicitly explaining why Opvee was not approved for non-prescription use or use with a standing order. When this information was shared with Indivior, the company falsely advised that the sheriff’s office could simply write its own standing order for Opvee. The sheriff’s office then purchased $22,500 worth of the drug from Indivior, in violation of state law. In April 2025, Attorney General James reached a settlement with the sheriff’s office, ensuring it would only use authorized overdose reversal drugs moving forward. Attorney General James also this week reached a $35,000 settlement with PrimeCare, the correctional setting health care company that wrote the standing order for Opvee despite knowing it was not approved for such purposes.

As a result of OAG’s investigation, Indivior must refund the full $22,500 purchase price for the improperly sold doses and accept the return of all unused units. Attorney General James is also requiring Indivior to overhaul its marketing practices in New York, ensuring its sales staff accurately represent Opvee’s legal status and refrain from making any false or misleading claims about the drug’s approvals or effectiveness moving forward. The company is also prohibited from selling Opvee to public agencies in New York unless and until it is expressly authorized by state regulators. The OAG will monitor Indivior’s compliance and review its enhanced training materials within 60 days.

Public health officials discourage the use of Opvee because of its painful and potentially dangerous withdrawal effects for those recovering from an overdose. Research shows that Opvee is no more effective than Narcan, which has long proven to be an effective tool for reversing overdoses. Not only does Opvee not improve survival rates or patient outcomes, but its longer duration can also cause severe and prolonged withdrawal symptoms, lasting up to 12 hours compared to Narcan’s typical 90 minutes. This extended withdrawal is painful for patients and puts them at risk of life-threatening conditions for longer than necessary. The American College of Medical Toxicology (ACMT) and American Academy of Clinical Toxicology (AACT) have cautioned that replacing Narcan with Opvee for first responders could cause unnecessary harm without providing any added benefit. Attorney General James’ settlement ensures that New York’s overdose prevention efforts remain centered on naloxone, which has been proven safe, effective, and accessible for decades.

In July 2024, Attorney General James secured an $86 million multistate settlement with Indivior for contributing to and profiting from the opioid crisis with its opioid use disorder treatment medication. Attorney General James alleged Indivior targeted sales to dangerous prescribers, including pill mills, and failed to monitor suspicious orders, allowing its products to fuel addiction.

Attorney General James is a national leader in combating the overdose crisis. To date, Attorney General James has secured more than $3 billion to support New York opioid abatement, treatment, and prevention efforts from companies that fueled the opioid epidemic, including Purdue, Mylan, Amneal Pharmaceuticals, Hikma Pharmaceuticals, Teva Pharmaceuticals, Johnson & Johnson, Mallinckrodt, Allergan, Endo, McKesson, Cardinal Health, and Amerisource Bergen. Attorney General James has also led multistate coalitions in reaching settlements for billions of dollars with CVS, Walgreens, and Walmart for their roles in failing to properly regulate opioid prescriptions. Additionally, Attorney General James and a bipartisan coalition of states secured settlements with consulting firm McKinsey & Company and the marketing firm Publicis Health for their role in fueling the opioid crisis. 

“Naloxone works and saves lives. We do not need ‘higher-dose’ overdose reversal medications like Opvee. These so-called ‘stronger’ overdose reversal medications are at best unnecessary — and at worst, can lead to more fatal overdoses as people experiencing excruciating withdrawals from Opvee turn to using more drugs to manage their pain,” said Laura Guzman, Executive Director of the National Harm Reduction Coalition. “No company should be exploiting people to profit off the overdose epidemic. Every day, we are losing our loved ones to preventable overdose deaths. We must expand life-saving harm reduction programs and services, including naloxone distribution — 4 milligrams or less — to communities that need it most. Lives depend on it.”

“We applaud the actions Attorney General James has taken to stop Indivior’s aggressive marketing of their nalmefene product in New York state,” said Dr. Kelly S. Ramsey, Immediate Past President of the New York Society of Addiction Medicine. “Opioid overdoses can be reversed with standard naloxone, while nalmefene products and higher dose naloxone (> 4 mg intranasal and >0.4 mg intramuscular) carry additional risks for people who use drugs, including worse opioid withdrawal in persons who have overdosed and receive these medications. We appreciate New York’s role in amplifying evidence-based overdose response and shutting down false claims by pharmaceutical companies.”

“We appreciate the Attorney General’s diligence in ensuring that the predatory practices of big pharma do not continue unchecked,” said Alexis Pleus, Executive Director of Truth Pharm. “In an epidemic born of greed, there is no place for greedy actors to profit at the expense of people’s lives. We cannot and will not accept medications that intentionally, and without medical justification, increase the suffering of people struggling with addiction. That is exactly what Opvee does.”

“Indivior, the manufacturer behind the harm-inducing drug Opvee, bears responsibility for fueling the opioid crisis alongside Purdue and other corporations. Now, they have shifted their marketing and training strategies to skirt accountability by bypassing our State Department of Health to lure unsuspecting municipalities to use their product in overdose prevention programs,” said Joyce Rivera, Founder and President of St. Ann’s Corner of Harm Reduction. “Let’s be clear: efforts to reduce drug overdoses must be based on science and not dictated by corporate interests or market trends. The illicit drug supply is in constant flux with varying amounts of opioids, stimulants, sedatives, and inert additives. True, sustainable overdose prevention services center harm reduction and are built on community-driven solutions shaped by the wisdom and lived experience of those most affected, not by the companies that helped create the crisis in the first place.”

“My 19-year-old son Harris had co-occurring disorders and died by accidental overdose, so I know all too well the devastating consequences when lifesaving tools are not easily accessible. I often think that if naloxone had been more widely available when Harris needed it, his life might have been saved,” said Stephanie Marquesano, Founder and President, the harris project. “That’s why it is so concerning when a company promotes a prescription-only product as if it were interchangeable with naloxone, creating confusion that can put lives at risk. At the harris project, we are committed to ensuring young people and their loved ones have the support, education, and interventions they deserve. I am deeply grateful to Attorney General James for taking action to stop misleading marketing and protect communities. Every life saved is an opportunity for recovery, and actions like this give individuals and their loved ones hope.”

“I applaud the Attorney General and her staff for their continued investment in addressing the opioid overdose crisis in New York,” said Ashley Livingston, Co-Chair, Friends of Recovery Warren and Washington. "Holding companies accountable for misleading marketing practices is crucial for public health. The $22,500 recoupment may seem like a small amount compared to the scale of the crisis, but it sends a clear message to other companies that deceptive practices won’t be tolerated in New York. I am grateful to have an Attorney General who continually stands up for vulnerable populations.”

“Misleading marketing of unapproved medications endangers lives and undermines public trust. I commend Attorney General James for her leadership in holding Indivior accountable and taking action to protect New Yorkers,” said Westchester County Executive Ken Jenkins. “Unlike naloxone, Opvee has not been authorized by the Department of Health for use in overdose prevention programs. Yet, Indivior marketed and sold the drug as if it were an alternative, misleading the public and hindering critical prevention efforts. At the end of the day, the safety and well-being of our residents is our top priority, and I am pleased that this settlement ensures stronger protections.”

“It is important to hold pharmaceutical profiteers liable for the great damage they have caused to our communities and the lives they’ve taken. In this case, Indivior first exacerbated the opioid epidemic and then profited from it by deceptively promoting an unapproved drug for it,” said Erie County Executive Mark C. Poloncarz. “Cold and callous, Indivior demonstrated the importance of their bottom line over human lives. Erie County did not procure any nalmefene as it had not been approved by NYSDOH for use without a prescription despite the company’s false assurances, and I thank Attorney General James for holding Indivior accountable for their egregious behavior.” 

“Naloxone remains the proven, safe, and effective tool for reversing opioid overdoses,” said Monroe County Commissioner of Public Health Dr. Marielena Vélez de Brown. “Misleading claims about alternatives put lives at risk and create confusion at a time when clarity saves lives. We thank Attorney General James for her continued leadership in ensuring our communities have access to trusted, evidence-based treatments that protect families and save lives.”

“I applaud the Attorney General and her team for their work in holding Indivior accountable,” said Senator Pete Harckham. “As we fight the opioid crisis, the last thing we need is confusion caused by unapproved opioid reversal agents being sold to first responders or other community health organizations.” 

This matter was handled by Assistant Attorneys General Susan Lambiase of the Health Care Bureau and Tina Peng of the Law Enforcement Misconduct Investigative Office, as well as Special Counsel for Social Justice Amanda Masters. The Health Care Bureau is led by Bureau Chief Darsana Srinivasan, and the Law Enforcement Misconduct Investigative Office is led by Bureau Chief Tyler Nims and Deputy Bureau Chief Lillian Marquez. Both are part of the Division for Social Justice, which is led by Chief Deputy Attorney General Meghan Faux and overseen by First Deputy Attorney General Jennifer Levy.

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