Pharmaceutical manufacturer Indivior has ceased marketing its controversial overdose-reversal medication Opvee following a settlement with New York Attorney General Letitia James, marking a significant victory for harm reduction advocates who had warned about the drug's severe side effects and questionable benefits.
The settlement, announced on September 30, requires Indivior to refund $22,500 in taxpayer money used to purchase Opvee in New York and accept the return of all unused units. Just two days after signing the agreement, the company began circulating letters to stakeholders nationwide stating it had "discontinued promotion" of the medication.
Settlement Details and Violations
Attorney General James found that Indivior illegally marketed Opvee to public agencies and local sheriffs despite the state's health department not authorizing it for use in settings where nonmedical professionals administer the medication. The company falsely claimed Opvee could be used the same way as Narcan, the state-approved over-the-counter naloxone product.
"Indivior cannot rewrite its history and exploit this drug crisis for profit," James said in a statement. "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."
The investigation revealed that Indivior advised a sheriff's office to write its own standing order for Opvee, despite knowing the drug wasn't approved for that use. That office subsequently purchased $22,500 worth of the medication, violating state law. James also announced a separate $35,000 settlement with the healthcare provider that issued the standing order.
Safety Concerns and Medical Opposition
Harm reduction advocates had consistently warned that Opvee's ultra-potent active ingredient nalmefene could potentially send overdose victims into agonizing withdrawal symptoms. Unlike Narcan, which typically wears off in 90 minutes, Opvee's effects can last up to 12 hours, triggering severe withdrawal symptoms that could incentivize patients to use opioids again to alleviate their discomfort.
Leading professional organizations, including two top toxicology groups, warned that using nalmefene-based medications like Opvee instead of naloxone may not yield better overdose-reversal results and "could potentially cause harm."
"Naloxone works and saves lives," said Laura Guzman of the National Harm Reduction Coalition. "Stronger medications like Opvee are unnecessary and dangerous."
Company's Troubled History
The settlement represents another significant setback for Indivior, which has encountered frequent controversy despite being among a select few pharmaceutical companies developing products to address the drug overdose crisis. The company's best-known product, Suboxone, is viewed as the standard version of buprenorphine for treating opioid addiction, while its newer monthly injection Sublocade has shown even greater effectiveness.
However, Indivior has faced settlement agreements worth over $500 million after lawsuits claimed it illegally suppressed generic competition for Suboxone. In 2024, James helped secure an $86 million settlement between Indivior and 16 states for the company's alleged failure to monitor suspicious orders, thereby fueling "pill mill" clinics.
Market Performance and Industry Context
Indivior had already acknowledged substantial challenges in marketing Opvee, writing in its 2024 annual report: "We are somewhat disappointed that we are not further along the adoption curve. We recognized when we launched Opvee that the harm reduction advocates would be vocal, but the voice has been louder than we expected."
The company's retreat from Opvee reflects broader industry dynamics in the overdose-reversal market. As the opioid crisis accelerated and fentanyl dominated the U.S. drug supply, some groups reported difficulty reversing overdoses with standard naloxone. Drug companies responded by manufacturing high-dose, mechanically complex, and vastly more expensive products, but with little data suggesting improved life-saving outcomes.
Most harm reduction organizations continue using lower-dose nasal sprays like Narcan or generic intramuscular naloxone donated largely by Pfizer.
Ongoing Federal Implications
Despite discontinuing promotion, Indivior stated that Opvee will remain available for doctors to prescribe or public entities to purchase. It remains unclear whether New York's scrutiny will affect Opvee's uptake in other states or impact an ongoing federal purchase agreement worth as much as $113.8 million.
The settlement follows a separate New York state study released in early 2024 showing that higher doses of naloxone were not associated with higher overdose survival rates but were more likely to cause severe withdrawal symptoms, including vomiting.
"In an epidemic born of greed, there is no place for greedy actors to profit at the expense of people's lives," said Alexis Pleus, executive director of Truth Pharm. "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."
