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April 8, 2024

Purdue seeking FDA approval of auto-injector for drug to treat opioid ODs

Photo | Contributed Purdue Pharma's Stamford headquarters.

Purdue Pharma has asked the federal Food and Drug Administration (FDA) to approve a new, auto-injectable form of one of its drugs to treat opioid overdoses.

The Stamford-based biopharmaceutical company said Monday that the FDA has accepted its filing of a new drug application for the auto-injector delivery form of nalmefene hydrochloride injection. 

If the auto-injector is approved, it would be the second treatment containing nalmefene developed by Purdue to specifically treat the growing number of opioid overdoses nationwide, the company said.

The U.S. population is familiar with auto-injectors, which are used to treat severe allergic reactions, Purdue said. If approved by the FDA, the nalmefene auto-injector could be used by healthcare professionals and first responders, as well as by those without medical training, it said.

Purdue President and CEO Dr. Craig Landau said that if the FDA approves the auto-injector, Purdue will “distribute this medication for no profit, as part of our commitment to help abate the opioid crisis.”

Purdue said it currently distributes the drug to medical professionals at no profit to treat opioid overdoses.

The FDA has granted a priority review for the drug application and assigned a goal date of Aug. 7, 2024. Priority review status means that FDA will expedite the process to evaluate a drug that would significantly improve treatment of a serious condition.

Purdue Pharma is the maker of OxyContin, a painkiller that became the subject of numerous lawsuits because the company misled physicians and the public about its highly addictive nature. 

In 2020, the company agreed to plead guilty to three federal criminal charges, pay more than $8 billion and close down the company, with its assets used to create a new, government-controlled entity.

Following objections from several states, an amended settlement was reached in 2022, in which the company agreed to pay more than $10 billion.

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