Zogenix Inc. (ZGNX)’s pure hydrocodone painkiller Zohydro may be abused at a greater rate if approved than combination products on the market, U.S. regulators said.
Food and Drug Administration staff asked outside advisers in a report today to weigh the effectiveness of the extended- release pill against its risk of abuse. The advisers will meet Dec. 7 to decide whether to recommend the medicine’s approval.
Zogenix, whose $38 million in revenue last year came from migraine injection Sumavel, may get more than $200 million in sales from Zohydro, Annabel Samimy, a Stifel Nicolaus & Co. analyst in New York, said in a note to clients last month. Zogenix, based in San Diego, touts Zohydro as the only pure alternative to hydrocodone-combination painkillers, such as the acetaminophen-mixed Vicodin, which carry a risk of liver injury.
“It is expected that Zohydro ER (if approved and marketed) will be associated with higher levels of abuse than the hydrocodone combination products,” the FDA staff said in the report.
Zogenix fell 5.1 percent to $2.40 at the close of New York trading. The shares have gained 8.1 percent this year.
The 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 million tablets dispensed, more than three times as many as the 24 visits per million combo tablets. There were 14 visits per million hydrocodone-combo tablets dispensed.
The FDA is scheduled to decide whether to clear the painkiller by March 1 and doesn’t have to follow the panel’s recommendations.
Because of the extended release of the active ingredient, Zohydro would be used twice daily instead of every four to six hours like the combination drugs. Consumers might have easier access to the combined medicines because those have fewer regulations than pure hydrocodone.
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 didn’t create a tamper-resistant formulation for Zohydro to prevent users from crushing the narcotics and amplifying the effects.
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, a category that comes with stricter controls on sales that requires more doctor interaction with patients than Schedule III, which combination drugs fall under. The DEA has asked the FDA to review rescheduling the combo treatments to require tighter oversight.
Zogenix is looking at bringing on a partner or expanding its internal sales force to about 150 representatives if Zohydro wins approval, Hawley said on the earnings call. The company plans to begin sales of the painkiller in June if approved, he said.
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