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

Fatal car crash reported on Highway 92 near Lake Stevens

The 3 p.m. accident and investigation stopped traffic in both directions near Machias Road.

Firefighters come to the rescue and give mom new stroller

Donations to the Good Neighbor Program covered the $143.20 cost.

Mayor tries new tactic to curb fire department overtime

Stephanson says an engine won’t go into service when the only available staff would be on overtime.

Cheering families welcome Kidd, Shoup after 6 months at sea

“I get back Daddy back today,” said one homemade sign at Naval Station Everett.

Paine Field fire chief will be allowed to retire

In his letter, the airport director noted Jeff Bohnet was leaving while under investigation.

Stanwood man, 33, killed in crash near Marysville

Speed may have been a factor, the sheriff’s department said.

County plans to sue to recoup costs from ballot drop-box law

A quarter-million dollars could be spent adding 19 ballot boxes in rural areas.

County frees up $1.6M for Everett’s low-barrier housing

The plan appears on track for the City Council to transfer land ahead of next month’s groundbreaking.

Jamie Copeland is a senior at Cedar Park Christian Schools’ Mountlake Terrace campus. She is a basketball player, ASB president, cheerleader and, of course, a Lion. (Dan Bates / The Herald)
Cedar Park Christian senior stepping up to new challenges

Jamie Copeland’s academics include STEM studies, leadership, ASB activities, honor society.

Most Read