Zogenix: No Overdoses or Diversion Caused by Zohydro

Zogenix: No Overdoses or Diversion Caused by Zohydro

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.

Zohyrdo-173x135A 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.”

Authored by: Pat Anson, Editor

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Andrea Nixon

I agree with Julie Golemons comment 100 % ! My existence is pretty miserable, and without fail, I’m up in the middle of the night in pain and sweating, after about 4 hours of sleep! Try to get cooled down & take a pill, try to get back to sleep, only to wake in pain again typically.
I can’t tell you how many years this has been going on…( too many ! )
I have prescription coverage through Medco, so I guess it will never be a medication that I’ll ever get to try. I can’t afford to pay out of pocket.

Julie Golemon

I think the Zohydro sounds like the perfect medicine for my chronic pain conditions because it lasts 12 hours instead of 4-6 hours like Vicodin. It would give me more pain control throughout the day without having to keep up with the time of when I need to take the vicodin before it completely gets out of my system, therefore I’m not on a pain roller coaster throughout the day. also it would give me a better chance at bedtime to control my pain so I could get better quality of sleep for my body to heal and recharge for the next day.
This would be a Godsend for my life because without pain control there is no decent quality of life to do even simple things for myself instead of being taken care of. I am on total disability but want some control of my life so as to be able to enjoy whatever time I have.

Ed

Kinda makes the continuing efforts to get the HHS or FDA to pull Zohydro seem pretty silly.

RN

Addicts will take whatever they can get their hands on and Zohydro is very expensive and very hard to get, maybe1 in 10 pharmacies will even stock it. Its a whole lot easier and cheaper to get your hands on a bottle full of generics. This company is doing all the right thinks to prevent diversion, such as educating prescribers and pharmacies and offering pill bottle locks and safes. What generic company is doing all that. None. The bottom line is that this product threatens the future business for Purdue, Teva, Mylan, Pfizer, etc. and they don’t like it. Easy fix, splash a bit of money around and you can get politicians and writers to jump through hoops, doesn’t exactly take a cattle prod.

Great news considering that past October, once the 90 day grace period has passed, patients may as well get the new long acting drug that appears to last the entire twelve hours unlike other long acting medications such as MSContin and Oxycontin which require a rescue medication in between when the med wears out at eight hours.

Great that the “devil drug” that was so many times stronger has yet to kill anyone, to the maker;s knowledge. Something finally went our way, pain patients!

Mark Maginn

Yes, the sky didn’t fall.

BL

I’ve read the clinical trials and it appears that Zohydro is a very good drug for the control of chronic severe pain. Unfortunately, this will put it at the top of the list for those who divert and abuse these drugs. There hasn’t been enough time to adequately determine the extent to which Zohydro will be diverted and abused.