Abuse-resistant OxyContin will be only version available

LOS ANGELES—Three years after it approved a version of the opioid analgesic OxyContin designed to discourage the painkiller’s abuse, the Food and Drug Administration has effectively barred the original form of the drug from ever reaching the legal U.S. market. The agency says it will approve no new applications from generic drug manufacturers to produce cheaper versions of OxyContin in its original form.

OxyContin has been one of the nation’s most abused prescription painkillers, in part because as those addicted to the potent drug built up tolerance for it, they could easily ground it up or dissolve it in water, making the potent extended-release drug easy to snort or inject for a faster, more intense high.

But in April of 2010, the FDA approved a reformulated version of the drug that was resistant to crushing, breaking, chewing or dissolving in water. The newer version is virtually unbreakable, and when dissolved in water, turns into a jelly-like mass.

The reformulated version was produced by the pharmaceutical maker Purdue Pharma, which originally brought the medication to the U.S. market in 1995. But in approving Purdue’s reformulated version in 2010, the FDA simply called it “a step in the right direction.” The agency withheld judgment on whether the new OxyContin constituted enough of an innovation to render the original version of the drug unmarketable.

As Purdue Pharma’s exclusive patent rights to produce OxyContin in its original form approached its expiration date this year, generic pharmaceutical companies began eyeing the profitable prospect of seeking the FDA’s approval to produce a low-cost version of the original OxyContin.

With Tuesday’s announcement by the FDA, that won’t happen, and Purdue Pharmaceuticals will have several more years of exclusive patent rights over its abuse-resistant formulation of OxyContin. That will likely keep high the cost of the prescription” pain medication—now sold at retail pharmacies at between $5 and $8 per pill.

That decision came after Purdue Pharma presented the FDA with laboratory and real-world studies of the reformulated OxyContin’s abuse potential. “Purdue recognizes that abuse of prescription opioid analgesics is a persistent and significant public health problem,” the company said in a statement released Tuesday. The company said it would continue to study the problem of OxyContin abuse and report its findings to the FDA.

“While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin,” said Dr. Douglas Throckmorton, deputy director for drug regulation in the FDA’s Center for Drug Evaluation and Research.

OxyContin’s reformulation has had a dark side: in a July 2012 letter to The New England Journal of Medicine, a group of researchers revealed that after OxyContin’s reformulation, droves of people addicted to the painkiller but thwarted by the new formulation were turning to a more dangerous drug—heroin—a development likely to result in an uptick of overdoses and deaths.

More in Local News

Herald photos of the week

A weekly collection of The Herald’s best images by staff photographers and… Continue reading

John Miller, congressman, author activist, has died

He was known for his dedication to the marine industry, energy and human rights.

Church takes a quiet, contemplative approach to worship

Alternative services at First Congregational Church of Maltby offer “a good deal of silence.”

Search on for mildly autistic boy in Lynnwood

Six-year-old was last seen in his home around 2:30 p.m. Monday.

Funds up for council vote would aid conservation district

District stands to receive an extra $1 million each year, if the County Council gives its approval.

Snohomish County hosts its annual Focus on Farming conference

The event features a trade show as well as talks on agriculture, jam-making and more.

Supportive housing for man accused in attacking his mother

Mental state impaired man’s ability to appreciate the wrongfulness of his actions, judge rules.

Lynnwood mayor challenged by councilman in general election

Three City Council members also are facing challengers on the Nov. 7 ballot.

‘Horrific’ child-porn case: Former Arlington man sentenced

Raymond Devore, arrested in 2015, had a cache of disturbing photos and video on his cellphone.

Most Read