Zohydro Sales Growing

Zohydro Sales Growing

Sales of Zohydro – a controversial new hydrocodone painkiller – are growing steadily, despite efforts in some states to ban or restrict the prescribing of the opioid pain medication.

In a conference call with analysts, the chief executive of San Diego-based Zogenix (NASDAQ: ZGNX) said the reaction from physicians and patients to Zohydro was “overwhelmingly positive,” with no sign that it was being abused, misused or diverted.

“Quite honestly we’ve seen no sign of that. In fact we’re very pleased that although we’re only five months into this we’re actually very pleased with the profile we’ve seen. We have fairly extensive surveillance tools and a group of outside experts who are looking at all the data that is available. So we believe in what we’re doing. We believe it’s worked thus far.” said CEO Roger Hawley.

ZohydroA wave of controversy has surrounded Zohydro – the first single ingredient hydrocodone painkiller sold in the U.S. — since its introduction in March. Some addiction treatment experts have claimed the new painkiller — which does not come in an abuse deterrent formula — will fuel a new wave of narcotic addiction and overdoses.

So far nearly 15,000 prescriptions for Zohydro have been written by nearly 2,800 prescribers in the U.S.

In the first four weeks of July, there were 4,076 prescriptions for Zohydro, an increase of 74% compared to the first four weeks of April.

Zohydro’s introduction has not been trouble free. The Governor of Massachusetts tried to ban all sales of the drug, but his emergency order was ruled unconstitutional by a federal judge who said it interfered with the authority of the Food and Drug Administration to regulate prescription drugs. Zohydro is already subject to schedule-2 controls under the federal Controlled Substances Act, the most restrictive schedule available for an FDA-approved product.

Other states, such as Vermont, require physicians to thoroughly evaluate patients, get patients to sign a treatment agreement and to check a prescription drug database to see if their patients abused other medications before Zohydro can be prescribed.

The biggest threat to Zohydro may not be restrictions on its use, but competition from bigger drug makers. Both Purdue Pharma and Teva Pharmaceuticals are developing their own “pure” hydrocodone products, but with abuse deterrent properties that make it harder for drug abusers to snort or inject. The FDA has given Purdue’s new drug application a “priority review” and the agency’s decision is expected in October.

FDA officials have suggested that if a new hydrocodone product is approved with anti-abuse properties, Zohydro may be removed from the market.

“If and when (Purdue), or another manufacturer, are able to create an abuse-deterrent formulation that remains safe and effective for patients, we would certainly give serious consideration to assuring that any formulations (without a deterrent) are removed from the market,” said Bob Rappaport, Director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products.

“There’s no real precedent there. So I cannot give you clarity,” said Zogenix’s CEO when asked if he was worried that Zohydro might be pulled from the market if and when a competing product emerges.

Until the introduction of Zohydro, the only 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. with over 130 million prescriptions annually.

Zogenix, which claims Zohydro is safer because it does not contain acetaminophen, estimates there are 2.4 million patients in the U.S. who use hydrocodone “chronically.”

“It seems to me there’s adequate room for a competitor and there’s plenty of business potential. There are a lot of prescribers of hydrocodone and a lot of patients using it,” said Roger Hawley.

“It’s a very large market and the hydrocodone class has the largest number of patients using the hydrocodone molecule. Oftentimes having a competitive product involved actually can help grow the market. We’re not afraid to compete.”

Hawley said up to 80% of the Zohydro prescriptions dispensed so far have been reimbursed by insurers, including Medicare. The number of Medicare-covered prescriptions is higher than what the company expected.

He said the company was “surprised” to learn last week that Express Scripts Pharmacy was excluding Zohydro from its national preferred drug formulary starting in 2015. Express Scripts customers will still be able to get Zohydro if they have prior authorization, he said.

Authored by: Pat Anson, Editor

There are 13 comments for this article
  1. Joyce at 5:59 pm

    I’m sick of asking for my pain meds. I have one kidney and stage 3 Kidney disease, I have DJD. An DDD. And Fibomagia and chronic pain for years, and doctors are know help. I would be so happy to be out of pain. I can’t even cook a full meal. On top bladder cancer return and I need something like this. I can’t wreck my liver at a loss for anymore words HELP FOLKS WHO ARE IN NEED OF RELIEF.

  2. lisa at 2:46 pm

    I can understand the worry of overdoses BUT us patients who go by t rules n like I pass all my tests,n still am treated differently. N what’s up with your doctor taking away ur pain meds lately? I’ve been made to take only half of my pain meds n I don’t know if its t doctor or sea.others in his office have been treated t same n have been going to him for years.I’m so tired of this n finding a good doctor who actually cares is hard to find.I’m so mentally and physically sick of t stress n pain.

  3. BL at 6:09 pm

    KC, New FDA Guidelines state that you aen’t suppose to take more than 4,000 mg Tylenol in a 24 hr period and no more than 650 mg every 4 hrs or 1,000 mg every 6 hrs. This is combined. Two Tylenol Arthritis is 1,300 mg and if you add Norco within 6 hrs that is 1,625 mgs and that is way, way too much Tylenol.

  4. Cynthia French at 1:54 pm

    People in chronic pain aren’t looking for narcotics, they are looking for pain control!

  5. KC at 10:02 am

    I was told a while back,by my doctor, that I could take up to 3000mg daily of Tylenol ( I know recent studies have shown this isn’t a good idea). I have started taking Tylenol Arthritis (650mg pills) 2 pills at a time, several times a day. I too, have my liver levels checked all the time for liver damage. I also take Norco (7.5/325mg) for pain. Due to other health issues, I am not able to take NSAIDs, but I have unexplained inflammation throughout my body. I am in a catch 22. My issue is that if you are in chronic pain and do take meds, you are treated differently. I just wish that they would come up with something that would help all day and it didn’t have to be so difficult to get. I always feel so weird calling my doctor for my refills. I feel like I am judged at the doctors office as well at the pharmacy (everybody is kind to me, its just how I feel). I live in one of the states in the top 3.
    I too, would LOVE if I didn’t have to take any medications or would be happy just taking one thing. What really gets under my skin, is the fact that people act like I enjoy taking all of these different meds and just hanging out in the bed all the time. I just want to feel normal and have my life back! Chronic pain changes people. I know that it has changed me. Don’t lump everyone together because there are a lot of folks who really suffer. I feel we are overlooked and it’s not right.

  6. BL at 4:47 pm

    Eduardo, the reason tylenol is added to other pain medicaltions is because the tylenol is suppose to make the other ingredient stronger.

  7. Susan at 3:22 pm

    In response to the Tylenol issue: I am tested on a regular basis for liver problems because of the addition of acetaminophen to pain meds. If they can make something without it, it has to be an improvement.
    In regards to having an impact on abuse, here’s my opinion: people that abuse drugs could care less what they are ingesting, snorting, etc. It is very hard to live with chronic conditions. Please don’t ask me to take responsibility for those that are abusing the medications that offer a modicum of relief.

  8. cindy at 2:22 pm

    I would be happy to have a pain medication that does not contain acetaminophen. I am in chronic pain and use pain medication. I’m so tired of being accused of, or looked at being a addict because I use pain medication. Can’t the government stay out of these issues. It’s between me and my doctor. And of course the pharmacy companies, because they have to make their money. If there was a good alternative other than pain medication I would be happy to use it. Or maybe if they took chronic pain more seriously there would be something else by now.

  9. BL at 11:04 am

    Eduardo, in low doses acetaminophen isn’t toxic. That’s why the FDA made the manufacturers lower the max dose of it in prescription drugs to 325 mg by Jan 2014. The FDA has just moved to withdraw approval for prescription drugs that contain more than 325 mg acetaminophen.

    But, you can still buy Extra Strength Tylenol (Acetaminophen) OTC. And the 325 mg limit does not include OTC meds. I know the recent rates of liver toxicity have gone down. But, I wonder if it wouldn’t end up going back up because people are so desperate for any kind of pain relief. It may not be of any help in reducing chronic severe pain. But, desperate people do desperate things.

  10. Eduardo at 7:31 am

    If acetaminophen in high doses can be a liver toxin, why is it compounded with the other main medications?

  11. BL at 5:00 pm

    I’m also wondering if the FDA will withdraw their approval once Targiniq ER has been on the market for a while. I wonder what changes will take place regarding Zohydro sales in that time frame as well.

  12. Hank at 2:18 pm

    Going to be interesting to see how this one works out….
    Take the most prescribed and abused pain med in the world, strengthen it, keep out the tylenol, and expect …………..

  13. BL at 4:21 pm

    I wonder what percentage of these sales are for chronic non cancer related pain. I also wonder what percentage of the sales are for those who have private insurance, Medicare or Medicaid or pay cash.