The pharmaceutical manufacturer Indivior has stopped marketing Opvee, its controversial overdose-reversal medication, after two years of meager sales, outcry from harm reduction groups, and intense scrutiny from New York State’s top law enforcement official.
On Tuesday, New York Attorney General Letitia James unveiled a settlement with Indivior that she said would result in the company refunding all public dollars used to purchase Opvee in New York and accepting the return of all unused units. In the weeks before the settlement was announced, the company began circulating a letter to stakeholders nationwide stating it had “discontinued promotion” of the medication.
James’ announcement, and Indivior’s broader retreat, represent a significant win for the harm reduction community, which since Opvee’s approval in May 2023 had warned that the medication is no more effective than naloxone at reversing opioid overdoses but is substantially more expensive and carries severe additional risks. In particular, advocates warned that Opvee’s ultra-potent active ingredient nalmefene could potentially send overdose victims into agonizing withdrawal, causing unnecessary discomfort and incentivizing them to use opioids again to alleviate their withdrawal symptoms.
“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.”
Indivior, James said, marketed Opvee to public agencies and local sheriffs even though the state’s health department has not authorized it for use in settings where the medication is administered by nonmedical professionals. Separately, James announced settlements with one local sheriff’s department that bought Opvee and a company providing health care in prisons that wrote a standing order for the medication, both of which violated state policy.
Indivior has maintained that Opvee helps reverse overdoses and restore blood-oxygen saturation after prolonged periods without breathing more quickly than naloxone, and works faster.
Leading professional organizations, including two top toxicology groups, have warned that using all forms of the medication nalmefene, including Opvee, instead of naloxone may not yield better overdose-reversal results and “could potentially cause harm.”
The settlement marks a significant setback for Indivior, which has suffered repeated scandals despite being among a select few pharmaceutical companies working to develop products that could help address the drug overdose crisis. The company’s best-known product, Suboxone, is viewed as the standard version of buprenorphine, a common and highly effective medication used to treat opioid addiction. A newer Indivior medication, a monthly buprenorphine injection known as Sublocade, has been shown to be even more effective than buprenorphine taken daily.
But for all its efforts, Indivior has encountered frequent controversy, including settlement agreements worth over $500 million after a slew of lawsuits claimed it illegally suppressed generic competition for Suboxone. In 2024, James also helped secure an $86 million settlement between Indivior and 16 states resulting from the company’s alleged failure to monitor suspicious orders, thereby fueling “pill mill” clinics.
Indivior had already acknowledged the substantial headwinds it faced in marketing Opvee, writing in its 2024 annual report to investors: “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.”
Earlier this month, the company began circulating a letter stating that “effective August 26, 2025, Indivior has discontinued promotion for OPVEE (nalmefene) nasal spray 2.7mg.” The letter added that “Indivior has not taken this action due to safety or efficacy issues related to the product” and that the decision was based instead on “business reasons.”
The company’s backtrack on Opvee marks the latest chapter in a long-running, industry-wide saga regarding overdose-reversal products: both nalmefene, the active ingredient in Opvee, and naloxone. As the opioid crisis accelerated and fentanyl came to dominate the U.S. drug supply, some groups reported difficulty reversing overdoses with standard naloxone.
Drug companies, in turn, began to manufacture high-dose, mechanically complex, and vastly more expensive products, including high-dose EpiPen-style versions and a mechanized auto-injector that blared audio instructions through built-in speakers. But there was little or no data suggesting that such products were more likely to save lives, and many public health experts viewed the naloxone arms race as little more than a cash grab.
Even today, most harm reduction organizations use lower-dose nasal sprays, like Narcan, or generic intramuscular naloxone donated largely by the pharmaceutical giant Pfizer.
James’ settlement follows a separate New York state effort to rein in the pharmaceutical industry on naloxone and nalmefene products. In early 2024, amid a proliferation of high-dose naloxone formulations, the state’s health department released a first-of-its-kind study showing higher doses of naloxone were not associated with higher overdose survival rates but were more likely to cause severe withdrawal symptoms, including vomiting.
Despite Indivior no longer promoting Opvee, the company said in its notification letter that the medication will remain available for doctors to prescribe or public entities to purchase. It is unclear whether New York’s scrutiny will affect Opvee’s uptake in other states — or whether the federal government will move forward with an ongoing purchase agreement worth as much as $113.8 million.
Purdue Pharma, the drug manufacturer infamous for manufacturing and aggressively marketing OxyContin, also makes an injectable nalmefene product called Zurnai, which the Food and Drug Administration approved in 2024.
“In an epidemic born of greed, there is no place for greedy actors to profit at the expense of people’s lives,” Alexis Pleus, the executive director of the nonprofit advocacy group Truth Pharm, said in a statement. “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.”
STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.
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