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.
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.