Zogenix Inc. (ZGNX)’s pure hydrocodone painkiller Zohydro failed to win the backing of U.S. advisers, who said regulators should first take a closer look at measures to curb the abuse of opioids.
A Food and Drug Administration advisory panel voted 11-2 at a meeting today in Silver Spring, Maryland, that data submitted by the company fails to support approval. The agency must now decide by March 1 if it will follow the panel’s advice or allow San Diego-based Zogenix to sell the painkiller.
The review of Zohydro, touted by the company as a pure alternative to hydrocodone-combination products like Vicodin, spurred questions from the panel about ways to prevent abuse of opioids. Panel members said more risk measures, such as those that deter abusers from crushing the pills and snorting the drugs for a greater high, are needed for all such painkillers.
“Why not raise our standard as we move forward for society?” Alan Kaye, a panel member and chairman of the anesthesia department at the Louisiana State University School of Medicine in New Orleans, said at the meeting.
The government is weighing under what circumstances the FDA should consider requiring abuse-deterrent features for opioids, Bob Rappaport, the agency’s director of the Division of Anesthesia, Analgesia and Addiction Products in the Office of Drug Evaluation II, said during the meeting.
“Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue,” the company said in a statement. “However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen.”
Zohydro contains as much as 50 milligrams of hydrocodone, while Vicodin has 5 milligrams and is combined with acetaminophen. Zohydro is a twice-daily pain reliever while combination products are used every four to six hours.
Zogenix is in the early stages of studying a tamper- resistant pill, Stephen Farr, the company’s president and chief operating officer, said at the meeting. Zogenix didn’t create one during its first attempt at approval because of issues with choking and decreased effectiveness with pills that seek to guard against abuse, he said.
If Zohydro is approved, the drug may generate more than $200 million in sales, according to an estimate made by Annabel Samimy, a New York-based Stifel Nicolaus & Co. analyst, in a note to clients last month. Zogenix reported $38 million in revenue last year from the migraine injection Sumavel.
Zogenix’s shares were halted during the meeting. The stock rose 6.3 percent this year through yesterday.
The panel voted that Zohydro is effective and 9-5 that the drug is unsafe for those who are intended to take it.
“This drug will almost certainly cause dependence in the people who are intended to take it,” Judith Kramer, a panel member and professor of medicine at Duke University Medical Center in Durham, North Carolina, said during the meeting.
The drug may have a higher risk of abuse than other painkillers, FDA staff said in a Dec. 5 report.
The FDA staff estimated the difference in emergency room visits between Zohydro and the current drugs would be similar to that of pure oxycodone and combination-oxycodone products. Pure oxycodone resulted in 85 emergency room visits per 1 million tablets dispensed, more than three times as many as for those using combination tablets. There were 14 visits per million hydrocodone-combo tablets dispensed.
Purdue Pharma, a closely held company in Stamford, Connecticut, that made OxyContin, is researching a once-daily hydrocodone tablet that is supposed to be harder to manipulate and snort or use intravenously, the company said in a statement.
Prescription pain relievers are the second-most abused drug in the U.S. after marijuana, with hydrocodone-related emergency room visits more than doubling from 2004 to 2010, according to the Substance Abuse and Mental Health Services Administration. About 47 million patients received dispensed prescriptions for combination hydrocodone-containing prescriptions last year, according to the FDA report.
Zogenix submitted a risk mitigation strategy that mirrors a template the FDA released in July for all extended-release opioid products, Roger Hawley, chief executive officer of Zogenix, said in a Nov. 8 earnings call with analysts. The strategy requires makers of such drugs to educate prescribers and patients on safe use of painkillers and make training available for physicians on proper prescribing practices.
Zohydro uses Alkermes Plc (ALKS)’s drug delivery technology to provide extended release of the painkiller. Zogenix and Alkermes, based in Athlone, Ireland, agreed on Nov. 2 that Alkermes would be the exclusive manufacturer and supplier to Zogenix of Zohydro.
Zogenix said it expects the Drug Enforcement Administration to classify Zohydro, if approved, as a Schedule II product. The category comes with stricter controls on sales, requiring more doctor interaction with patients than Schedule III drugs, the category for combination products. The DEA has asked the FDA to review reclassifying the combo treatments to require tighter oversight.
If the drug is approved, Zogenix expects about 90,000 patients will be using the medicine about five years after sales begin, James Breitmeyer, Zogenix’s chief medical officer, said during the meeting
If Zohydro wins approval, Zogenix is considering finding a sales partner or expanding its internal sales force to about 150 representatives, Hawley said on the earnings call. The company plans to begin sales of the painkiller in June if it is cleared, he said.
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