Six months after the introduction of Zohydro, there have been no confirmed cases of diversion, overdose or death caused by the controversial painkiller, according to the chief medical officer of Zogenix (NASDAQ: ZGNX), the San Diego based company that makes the opioid pain medication.
“We’re very, very happy with the data that we’re seeing. We haven’t publicly disclosed it, but we’re extremely happy,” said Bradley Galer, MD. “We’re not aware of any diversion. Is it out there? I don’t know. But we’re not aware of any at all.”
Galer told National Pain Report the company has received a handful of reports about possible overdoses, but has not been able to confirm them.
A wave of controversy has surrounded Zohydro – the first single ingredient hydrocodone painkiller sold in the U.S. — since its introduction in March. The Governor of Massachusetts tried unsuccessfully to ban Zohydro and some addiction treatment experts predicted the painkiller would fuel a new wave of narcotic addiction and overdoses.
“The people who thought the sky was going to fall once this drug was on the market, it obviously hasn’t happened. And I don’t think it will happen, ” said John Burke, president of National Association of Drug Diversion Investigators,who serves on the Safe Use External Advisory Board for Zogenix, for which he receives compensation.
“Will there be abuse and diversion? absolutely. The drug’s hydrocodone. But I truly think, and again I’m prejudiced because I belong to the Safe Use and Advisory Board, but they have a lot of things in place to identify and react to it.”
In August, company officials said nearly 15,000 prescriptions for Zohydro have been written by nearly 2,800 prescribers in the U.S. Galer says sales continue to grow.
“We’re getting excellent feedback from physicians and patients,” he said.
Unlike most other hydrocodone products, Zohydro is designed for extended release 12-hour doses. Vicodin, Norco and other hydrocodone combination drugs typically don’t last as long and need to be taken every few hours for pain relief. They also contain acetaminophen, which in high doses can cause liver damage.
A study presented by Zogenix at PAINWeek in Las Vegas, a national conference of pain practitioners, found that the pain relief provided by Zohydro lasted the full 12-hours for most patients — eliminating the need for additional “rescue medication” for breakthrough pain. The study is based on Phase III clinical data conducted before Zohydro came on the market.
“More importantly, in the real world, we’ve talked to physicians who are using Zohydro. They’re saying it actually lasts 12 hours. They’re not having to use rescue drugs — if it all, rarely. So we truly believe it’s a durable 12 hours,” said Galer.
“Sleep is a big problem with chronic pain and if you don’t have those patients under control with sleep, its sort of a vicious cycle. So if you have it every 12 hours or every 24 hours, you want the medication to truly give them relief so they’re not waking up with pain.”
Over 130 million prescriptions are written annually in the U.S. for hydrocodone products — making it the most widely prescribed drug in the country. Zogenix estimates there are 2.4 million patients in the U.S. who use hydrocodone “chronically.”
The Drug Enforcement Administration recently announced that it is rescheduling hydrocodone combination drugs from Schedule III medications to the more restrictive Schedule II.
The rescheduling, which takes effect in October, means that pain patients taking Vicodin, Norco, Lortab or other hydrocodone painkillers will be limited to an initial 90-day supply and then will have to see a doctor each time for a new prescription when they need a refill. Prescriptions for Schedule II drugs also cannot be phoned or faxed in by physicians.
Zohydro is already classified as a Schedule II drug. Galer is unsure how the rescheduling will effect Zohydro sales — but he supports the DEA’s decision.
“It should have been done 20 to 30 years ago. Hydrocodone is potentially addictive and abusive and it should be a Schedule II drug, whether it has acetaminophen or not,” Galer said.
“I think it’s a positive thing for society. I truly do. I believe these drugs are being overprescribed, particularly Vicodin, and I think putting these restrictions on them will make prescribers think twice about whether to use it or not.”