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May 08, 2015 at 06:50 AM
(Bloomberg) — The abuse of a pain pill from Endo International P.L.C. and its generic copies is being blamed for an increase of hepatitis C among drug addicts — an unintended consequence of a regulatory decision meant to cut down on misuse.
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In 2010, U.S. regulators approved a hard-to-abuse version of Purdue Pharma L.P.’s OxyContin, which for a long time had been a drug of choice for opioid addicts. They didn’t just quit using, though, flocking instead to Endo’s extended-release Opana and its generics. The wide needle they use is also perfect for spreading blood-borne viruses.
In a report published Thursday, the Centers for Disease Control and Prevention (CDC) found a sharp rise in new hepatitis C cases in Kentucky, Tennessee, Virginia and West Virginia. Many of the infected were white, young and used injectable drugs. Co-author Jon Zibbell, a CDC scientist, has blamed the abuse of Opana for the surge of cases in some of the poorest areas of the U.S., though the drug wasn’t specifically mentioned in Thursday’s report.
“Opana is a drug that shouldn’t even be on the market,” Zibbell said at an April conference in Atlanta on prescription drug abuse. In an interview later, he said that while approval decisions are up to the FDA, doctors should consider the effectiveness of drugs whose active ingredient is absorbed by the body at a low rate when taken orally and at a much higher rate when injected.
Opana, in pill form, is approved by regulators for pain severe enough to require daily, long-term opioid treatment when alternative options are inadequate. Addicts frequently crush, cook and inject prescription painkillers, sharing needles and passing infections.
Still committed
Endo created an abuse-resistant form of Opana, its top-selling brand-name drug with sales of almost $200 million last year, and sells only that version now. But the FDA said in 2013 that the abuse-deterrent features weren’t good enough to justify blocking cheaper generic versions that aren’t made with the same kind of barriers to misuse.
“We remain committed to working with the FDA, DEA and other state and federal government and industry organizations to address misuse and abuse of opioids,” Endo said in a statement in response to Zibbell’s remarks.
The rising abuse of the pills has put the FDA in an awkward position — fighting to get legitimate patients access to affordable drugs that are also easy for addicts to tamper with. Excessive painkiller prescriptions, improper drug disposal and lack of education are also contributing to opioid abuse, the FDA said in a statement in response to questions regarding Zibbell’s comments in April.
Regulatory path
“We are working hard to help industry develop better abuse-deterrent formulations,” the FDA said. “The FDA is working with many drugmakers to support advancements in this area and help drugmakers navigate the regulatory path to market as quickly as possible.”
The FDA approved the current version of Opana in 2011, allowing the drug for legitimate users. Endo stopped shipping older versions the following year.
Every new hepatitis C infection carries a steep price. Gilead Sciences Inc.’s drug Harvoni, which can cure the liver disease in eight weeks, costs about $1,000 a day and has taxed state health budgets.
Actavis P.L.C., one of two makers of generic Opana, said it also works with government agencies and other organizations to fight prescription-drug abuse. Mark Donohue, a spokesman for the other generic Opana maker, Impax Laboratories Inc., didn’t respond to a phone message.
