FDA Suppors “Antagonist” Idea to Combat OxyContin
WASHINGTON, March 20–The Food and Drug Administration will expedite the review process of a newly formulated version of the painkiller OxyContin if its makers mix in an “antagonist” additive that would deter the abusive use of the prescription drug, Maine Attorney General Steven Rowe said.
At a closed meeting of the National Association of Attorneys General in Washington Tuesday, Rowe and other state attorneys general discussed the process of adding an antagonist to the drug with Dr. Cynthia McCormick, director of the FDA’s Division of Anesthetic, Critical Care And Addiction Drug Products. Rowe advocates such an additive, which would offset the potent pain-relieving effects of OxyContin if the pills were crushed.
If the prescription drug’s manufacturer, Connecticut-based Purdue Pharma, submits to the FDA a reformulated version that includes an antagonist, the federal agency will – upon submission – spend six months testing the safety and efficacy of the final product. The FDA generally spends about 11 months reviewing new drugs before approving them, FDA spokeswoman Kathleen Kolar said.
There are potentially adverse effects from the addition of the antagonist to OxyContin, Kolar said. Adding the antagonist could make OxyContin less effective for people who need it, she said. Asked if creating a reformulated OxyContin is feasible without such effects, Kolar said: “It’s definitely possible.”
If the FDA accepts the reformulated OxyContin, it will become the second prescription drug that contains an antagonist. The first is Talwin, another painkiller.
According to Rowe, McCormick, the FDA official at the attorneys general meeting, saw bright prospects for the additive. She “acknowledged the explosion in prescription drug abuse,” Rowe said. “This [antagonist] issue that I’m raising, she believes is an important point.”
Nevertheless, Rowe said, adding an antagonist would not solve the OxyContin abuse problem – an issue that prompted a Senate committee hearing last month that attracted certified nurse and mid-wife Nancy Green from Calais, a rural Maine community that has suffered from such abuse.
Rowe called the effort to abridge the prescription-drug abuse problem an “ongoing saga,” but said, “It is my belief that highly addictive opiates can be made tamper-resistant.”
Published in The Bangor Daily News, in Maine.
