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As the nation grapples with opioid abuse and misuse, one drug maker has failed to provide the Food and Drug Administration with a required study about the effect its powerful painkiller might have on teenagers.

At issue is Xartemis XR, which Mallinckrodt Pharmaceuticals received regulatory approval to sell two years ago. At the time, the company was also required to conduct a so-called postmarketing study to determine its safety in youngsters between 12 and 17 years old, according to FDA documents (see page 11).

But as of June 24, the company blew past a March 31 deadline for submitting its pediatric assessment. The drug maker also failed to respond to an April 25 “noncompliance” letter for which the FDA provided a new 45-day deadline to either submit the data or request an extension, according to the notice posted on the FDA web site.


The Xartemis XR labeling information notes that the safety and effectiveness of the medication was not established in anyone younger than 18, and that accidental consumption by children can result in poor ventilation, leading to a buildup of carbon dioxide, and death. The assessment was required under the Pediatric Research Equity Act.

Such missives are unusual. A total of 22 noncompliance letters have been sent to drug makers since 2013, according to the FDA site. The most recent were sent earlier this year to Merck concerning an antibiotic and to Purdue Pharma about an opioid painkiller, but both companies responded within a few weeks.


Generally, these letters go unnoticed, especially if companies scramble to respond. For this reason, the letter to Mallinckrodt stands out — as did the recent letter to Purdue — because they were issued at a time of intense national concern over overdoses and deaths attributed to narcotic painkillers.

Every day, more than 40 Americans die from overdoses of opioid painkillers, according to the US Centers for Disease Control and Prevention. In 2014, the drugs killed more than 28,000 people, and nearly 2 million Americans abused or were dependent on opioids.

This underscores a need for timely information, especially amid ongoing concerns about inappropriate and overprescribing. The CDC recently issued new guidelines urging primary care physicians to prescribe opioids only after other therapies have failed and to rely on the lowest possible doses.

Of course, Mallinckrodt may well respond to the FDA any moment now. We asked the drug maker why it has not submitted the data to the FDA and if or when it plans to do so.

[UPDATE: A company spokeswoman later wrote us to say the drug maker is “aware of the letter, and continue(s) to have an ongoing dialogue with the FDA regarding the complexities of pediatric research related to opioid pain medications. The company is committed to progressing discussions with FDA to ensure compliance with requirements, and we are preparing to engage with them on next steps.”] 

What happens if the company fails to comply and submit the data to the FDA? According to federal law, the agency could determine that Xartemis XR is misbranded. That would not lead to a product withdrawal, but the FDA could pursue an injunction or seizure proceedings.

This story was updated to include comment from Mallinckrodt.

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