Purdue Pharma LP plans to apply for regulatory approval of a tamper-resistant competitor to Zogenix Inc. (ZGNX)’s powerful pain pill, a move that could get its rival’s drug pulled from the market by U.S. regulators.
Purdue’s experimental drug hydrocodone bitartrate met the goal of reducing chronic low-back pain in a final-stage trial, the closely held company said today in a statement. Purdue’s pill is hard to crush and snort or inject, while Zogenix’s Zohydro ER doesn’t have abuse-deterrent features.
Zohydro’s potential for abuse led two U.S. senators this month to ask the Food and Drug Administration to pull the medicine from the market. The concern that the pill could be crushed and snorted was strong enough that when the drug was approved the U.S. regulator said its time on the market could be limited.
“If and when they, or another manufacturer, are able to create an abuse-deterrent formulation that remains safe and effective for patients, we would certainly give serious consideration to assuring that any non-abuse formulations are removed from the market,” Bob Rappaport, the FDA’s director of pain drugs, said in an Oct. 25 review of Zohydro’s approval.
Purdue plans to ask the FDA for a priority review that would cut two to three months off the 10 months the agency sets as a goal to examine applications, according to the company.
Gary Stiles, head of research and development of Stamford, Connecticut-based Purdue, said the company was pleased with the results. “We firmly believe that the market must move to all abuse-deterrent formulations,” he said. “There’s not a technical reason why we and others can’t do that,” he said in a telephone interview.
In Purdue’s study of 588 patients with low back pain, 65 percent saw pain improve by at least 30 percent, and 48 percent of patients had improvement of 50 percent, the company said in a statement. The most common side effects included constipation, nausea, vomiting and headaches, which are similar to side effects for other hydrocodone medicines. It hasn’t released full results.
In Zogenix’s clinical trial of Zohydro, 68 percent of patients taking the pill had low back pain reduced by at least 30 percent. Approved as the first painkiller made of pure hydrocodone, the drug started being distributed through select pharmacies at the beginning of March, the San Diego-based company said.
Zogenix said it should only be used by patients who can’t take other opioid-based painkillers. Use of the drug is strictly controlled, Zogenix said on its website.
While the drugmaker is working on its own tamper-resistant form of Zohydro, the company said in an e-mailed statement it wouldn’t be available until the end of 2016.
“Zogenix is fully engaged in providing abuse deterrence initiatives, including developing an abuse deterrent formulation of Zohydro ER,” the company said.
The shares of Zogenix have doubled since the drug was approved. Zogenix gained 12 percent to $4.54 in New York yesterday.
U.S. deaths from drug abuse have tripled since 1990, according to a 2013 report from the Centers for Disease Control and Prevention in Atlanta. There were 36,000 deaths in 2008, mostly from prescription drugs, and three out of four of those prescription overdose deaths were from painkillers.
Hydrocodone-based painkillers are the most-prescribed pharmacy drugs in the U.S. About 131 million hydrocodone products were dispensed in 2011, according to a January 2013 FDA report.
In letters to Health and Human Services Secretary Kathleen Sebelius, Democratic Senators Charles Schumer of New York and Joe Manchin of West Virginia have said Zohydro shouldn’t be available. “The FDA’s approval of Zohydro ER, in its current form, must be stopped before this dangerous drug is sold to the public,” Manchin said on March 10.
The FDA is tightening prescribing restrictions on pain drugs. In October, the agency said it would make rules re-classifying vicodin and other hydrocodone-based painkillers as schedule II substances, the second-most restrictive of a five-step scale that limits access based on addiction potential. The rules would restrict patients to a 90-day supply, compared to allowing five refills within six months. Zohydro is already classified as a schedule II drug.
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