New Haven Register (New Haven, CT)
FDA OKs Purdue opioid overdoses treatment
Critics, including Blumenthal, skeptical in light of company’s history
STAMFORD — Purdue Pharma, which is trying to settle several thousand lawsuits alleging it fueled the opioid crisis with deceptive OxyContin marketing, announced it has gained the Food and Drug Administration’s approval for a treatment for opioid overdoses.
The FDA approved Stamford-based Purdue’s new drug application for its Nalmefene hydrochloride injection. The treatment is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and the management of known or suspected opioid overdoses, according to the company.
Distribution of the treatment comprises one of the key components in Purdue’s proposed settlement of the lawsuits, but the company’s efforts to tackle the opioid crisis face major skepticism from critics who see the firm as one of the key culprits in the epidemic.
“Nalmefene is an important part of our commitment to help abate the opioid crisis,” Purdue CEO and President Craig Landau said in a statement. “This FDA approval is an example of our ongoing efforts to help provide much-needed treatment for patients and health care providers. Nalmefene will be an important treatment option to address the opioid crisis, which has accelerated during the COVID-19 pandemic and is being fueled by the increasing prevalence of illicitly manufactured synthetic opioids.”
The Nalmefene injection, in vial formulation, is intended to be used by health care professionals in emergency departments, according to Purdue. It is expected to be available by the middle of this year, and Purdue plans to distribute the treatment for no profit.
FDA officials could not immediately be reached for comment about why the agency approved the treatment.
Sen. Richard Blumenthal, D-Conn., who sued the company when he was state attorney general, said he had a number of concerns about the new treatment in light of Purdue’s history. While the company denies the lawsuits’ allegations, it pleaded guilty in 2020 to three criminal charges of conspiring to defraud the government and violate anti-kickback law. No individuals, however, were charged in connection with that plea.
“Given Purdue Pharma’s history of creating an epidemic of substance abuse and addiction — along with, in effect, the FDA enabling it — I have very strong questions about the effectiveness and safety of Nalmefene hydrochloride,” Blumenthal said in an interview. “They said they won’t profit, but given Purdue’s pattern of distortion and deception, I’m in the show-me camp. I’ll believe it when I see it.”
The distribution of the Nalmefene injection comprises one of several “public health initiatives” worth a total of about $4 billion that would be overseen by its successor company, according to Purdue’s settlement plan.
Through another of those initiatives, Purdue said it would distribute millions of doses of a generic version of buprenorphine-and-naloxone tablets to treat opioid dependence. In 2020, the FDA approved such a generic drug developed by Rhodes Pharmaceuticals, a subsidiary of Purdue.
An over-the-counter naloxone nasal spray to treat opioid overdoses, which Purdue said would be sold at a fraction of the cost of existing naloxone nasal sprays, comprises the other key public health initiative outlined in its settlement plan. Purdue has been supporting the spray’s development through a collaboration with another company, Harm Reduction Therapeutics.
Connecticut’s William Tong is one of eight state attorneys general who appealed a bankruptcy judge’s approval last September of the settlement plan, which the company values at a total of more than $10 billion.
Tong has said the proposed amount is too small, and he also objects to proposed legal protections for the Sackler family members who own the company. The Sacklers have agreed to contribute at least $5.5 billion and up to $6 billion to the settlement, but they would not do so without “third-party releases” that would shield them from current and future lawsuits related to Purdue’s opioids. Those releases would not prevent potential criminal prosecution.
Last December, another judge vacated the bankruptcy judge’s decision. Since early January, representatives of the appealing states, Purdue and the Sacklers have participated in meetings by phone, online and in person aimed at reaching an agreement. But the parties so far have not made a deal.
Tong declined to comment on the FDA’s approval of the Nalmefene treatment.
Separate from the Purdue litigation, Connecticut has signed onto a $26 billion settlement with distributors AmerisourceBergen, Cardinal Health, McKesson and drugmaker Johnson & Johnson — a pact that resolves opioidrelated claims of wrongdoing against those companies.
Elected officials on both sides of the aisle are proposing legislation that would ensure the approximately $300 million payout that Connecticut is set to receive from the settlement would be directed to efforts to tackle the opioid crisis.
There were 1,361 confirmed drug-overdose deaths in Connecticut in 2021, as of the first week of December, according to the state Department of Public Health. There were 1,378 overdose deaths in the state in 2020, an increase of 14 percent from 2019. The synthetic opioid fentanyl and fentanyl analogs were involved in 85 percent of the state’s overdose deaths last year and in 2020.