Posted on: September 30, 2025 01:45 PM

Share : Facebook Twitter Email Whatsapp

Attorney General James stops misleading marketing of unauthorized opioid overdose drug

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 e