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

Mukilteo crabber missing; his boat was found at Hat Island

Frank Urbick set out Thursday morning but did not return.

Police looking for leads in case of missing Snohomish man

Henry John Groeneveld, 63, was last seen on Monday, when he said something about going to “the river.”

Separate Everett fires send man to hospital, damage boat

The man was hospitalized for smoke inhalation from the early morning fire.

Police: He made an appointment, then tried to rob the bank

A lawyer is accused of donning a fake beard and telling a teller that a gunman was outside.

Drive-by shooting reported in Marysville neighborhood

Police said there was no evidence to indicate it was targeted at a specific person or property.

Celebrating the origins of Christmas

LDS church holds annual nativity festival featuring more than 600 sets.

Trooper’s car struck when he was arresting man for DUI

She drove away but was arrested for investigation of driving under the influence and hit-and-run.

Inslee’s budget solves school funding with help from carbon

His budget would use reserves to boost education, then replenish them with a carbon tax or fee.

Man, 29, injured by shots fired at Everett thrift store

The gunfire followed an argument in the parking lot of Value Village on Evergreen Way.

Most Read