Critics are skeptical as FDA approves Purdue Pharma treatment for opioid overdoses


STAMFORD — Purdue Pharma, which is trying to settle several thousand lawsuits alleging it fueled the opioid crisis with deceptive marketing of OxyContin, announced it had won Food and Drug Administration approval for a treatment opioid overdoses.

The FDA has 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 the effects of opioid medications, including respiratory depression, induced by natural or synthetic opioids, and the management of known or suspected opioid overdoses, according to the company. .

Distribution of the treatment is one of the key elements of Purdue’s proposed settlement of the lawsuits, but the company’s efforts to tackle the opioid crisis are being met with major skepticism from critics who view the company as one of the main culprits of the epidemic.

“Nalmefene is an important part of our commitment to help alleviate the opioid crisis,” Purdue CEO and Chairman Craig Landau said in a statement. “This FDA approval is an example of our continued efforts to help provide much-needed treatment to patients and healthcare providers. Nalmefene will be an important treatment option in addressing the opioid crisis, which has accelerated during the COVID-19 pandemic and is fueled by the growing prevalence of illicitly manufactured synthetic opioids.

Nalmefene injection, in a vial, is intended for use by healthcare professionals in emergency departments, according to Purdue. It should be available by the middle of this year, and Purdue plans to distribute the treatment not-for-profit.

FDA officials could not immediately be reached to explain 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 conspiracy to defraud the government and violate anti-bribery law. No individual, however, has been charged in connection with this plea.

“Given Purdue Pharma’s history of creating an epidemic of drug addiction and addiction – with, in effect, the FDA allowing it – I have very strong questions about the efficacy and safety Nalmefene hydrochloride,” Blumenthal said in an interview. “They said they wouldn’t take advantage of it, but given Purdue’s model 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 includes 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 such initiative, Purdue said it would distribute millions of doses of a generic version of buprenorphine and naloxone tablets to treat opioid addiction. 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 says would be sold at a fraction of the cost of existing naloxone nasal sprays, includes the other key public health initiative outlined in its settlement plan . Purdue supported the development of the spray 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. dollars.

Tong said the proposed amount was too low and also objects to proposed legal protections for members of the Sackler family who own the business. 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 protect them from current and future opioid-related lawsuits from Purdue. These releases would not prevent possible criminal proceedings.

Last December, another judge overturned the bankruptcy judge’s decision. Since early January, representatives from the appealing states, Purdue and the Sacklers, have participated in phone, online and in-person meetings aimed at reaching an agreement. But the parties have yet to reach an agreement.

Tong declined to comment on the FDA’s approval of the Nalmefene treatment.

Separate from the Purdue litigation, Connecticut has signed a $26 billion settlement with distributors AmerisourceBergen, Cardinal Health, McKesson and drugmaker Johnson & Johnson — a pact that resolves allegations of opioid-related wrongdoing against those companies .

Elected officials on both sides of the aisle are proposing legislation that would ensure that the roughly $300 million payout Connecticut is set to receive from the settlement would be directed toward efforts to address 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, a 14% increase from 2019. The synthetic opioid fentanyl and fentanyl analogues were implicated in 85% of the state’s overdose deaths last year and in 2020.

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