Zohydro 'Not a Public Health Risk'
/By Pat Anson, Editor
Eighteen months after the introduction of Zohydro, there is little evidence the controversial painkiller is being abused or diverted, according to a new report from a nationwide drug monitoring program.
"Zohydro is not a public health risk and has shown little tendency to increase over the time it has been available," stated the report by the Researched Abuse, Diversion and Addiction-Related Surveillance System (RADARS). "The drug is either not desirable or unavailable for abuse."
The report covered the first quarter of 2015. RADARS monitors hundreds of hospitals, poison control centers and addiction treatment clinics in the U.S. to track the abuse, misuse and diversion of prescription drugs.
"Everyone thought this was going to be some horrible, horrible thing. And it didn't materialize that way," said Errol Gould, PhD, Director of Medical Affairs for Pernix Therapeutics, which bought the rights to Zohydro from Zogenix Inc. earlier this year.
"There have been very few reports of people checking into treatment centers and reporting Zohydro ER as the drug they were abusing. In the past 18 months I can tell you there have been less than 40."
There was a storm of controversy surrounding Zohydro when it was introduced in March 2014. The first single ingredient hydrocodone painkiller sold in the U.S. was approved by the Food and Drug Administration over the objections of its staff and an advisory committee -- which warned there was a potential for Zohydro to be abused even more than other hydrocodone products.
Addiction treatment experts also predicted Zohydro would fuel a new wave of painkiller addiction and overdoses. The Governor of Massachusetts even declared a state of emergency and tried unsuccessfully to ban Zohydro sales in his state.
"All the media attention sort of scared people, so there weren't a lot of prescriptions written in the beginning," said Gould. "But now over time the prescription rate has picked up. But we're still not seeing diversion. The abusers already know what hydrocodone is like and they're not going out and looking for Zohydro when they can get other things that are more readily available to them."
Only about 1,600 prescriptions are being written for Zohydro each week, a tiny fraction of the 130 million hydrocodone prescriptions that are filled each year in the U.S. Prescribing of Zohydro is also closely monitored to keep it away from pain patients who might misuse or abuse it.
"I think the growth has been slow. Most of that has been because of the prior perceptions. We fully expect that to change over time. It just takes time to change people's views and minds. We've had a bit of an uphill battle," said Doug Drysdale, President and CEO of Pernix. "The good news here from RADARS is that the product is not being abused. And I think that's very encouraging."
The biggest problem faced by Pernix going forward may not be the hysteria over Zohydro's introduction -- but competition from rival drug makers.
Purdue Pharma has introduced its own "pure" hydrocodone product -- sold under the brand name Hysingla ER. Hysingla is designed to be taken once a day, while Zohydro is meant to be taken twice daily for chronic pain. Both products are sold in abuse deterrent formulas that make them harder for drug abusers to snort or inject.
Until the introduction of Zohydro, most hydrocodone products on the market were combined with acetaminophen, which at high doses can cause liver damage. Hydrocodone combination drugs such as Vicodin, Lortab and Lorcet are the most commonly prescribed and abused painkillers in the U.S. In 2014 hydrocodone was reclassified by the Drug Enforcement Administration as a Schedule II medication to make it harder to obtain.
