Addiction Experts Want FDA to Revoke Zohydro Approval

Addiction Experts Want FDA to Revoke Zohydro Approval

A coalition of addiction treatment experts, healthcare agencies and consumer groups is calling on the Food and Drug Administration to revoke its approval of Zohydro, a potent extended release opioid painkiller that will be introduced next month by San Diego based Zogenix Inc. (NASDAQ: ZGNX).

“We ask you to put the public’s health ahead of industry efforts. In the midst of a severe drug addiction epidemic, fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the FED UP! Coalition wrote in a letter to FDA Commissioner Margaret Hamburg.

The letter is signed by representatives from 42 different organizations, including Physicians for Responsible Opioid Prescribing (PROP), Phoenix House, Public Citizen, the American Society of Addiction Medicine, and Advocates for the Reform of Prescription Opioids.

In recent months, several congressmen and the attorneys general from 29 states have also written to the FDA, asking the agency to reconsider its decision to approve Zohydro, which will the first pure hydrocodone painkiller sold in the U.S.

Zogenix-ZohydroThe agency approved Zohydro last October over the objections of its staff and advisory committee, which warned there was potential for Zohydro to be abused even more than currently available hydrocodone combination products.

“The highest available dosage of Zohydro will contain 5 to 10 times more hydrocodone than Vicodin or Lortab. Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child,” said the letter from FED UP!

Combination versions of hydrocodone, such as Vicodin, typically contain acetaminophen and require dosing every 4 to 6 hours. Extended release Zohydro could be taken just twice a day for chronic pain. It is being introduced without a tamper resistant formula to discourage drug addicts from crushing or liquefy the pills in order to snort or inject the drug.

Zogenix claims Zohydro will actually be safer than other hydrocodone combination products because it does not contain acetaminophen – which can lead to acute liver failure if taken in high doses.

“Zohydro is not safer,” the FED UP! letter states. “For patients unable to tolerate acetaminophen, many opioid formulations made without acetaminophen are already available. There is no need for another high-dose, single-entity opioid.”

There was no immediate response to the letter from the FDA.

“We are confident in the decision by the U.S. Food and Drug Administration to approve Zohydro ER after an extended, 18-month, comprehensive and thorough review process.  The FDA concluded that the benefits of Zohydro ER outweigh the risks,” Zogenix said in a statement.

Zogenix is preparing for Zohydro’s commercial launch in early March. The company recently said the painkiller was ready for shipment to wholesalers and that adequate inventory is in place to meet anticipated demand for the drug.

“I’m worried about their plan to market the drug for back pain and other common problems,” said Judy Rummler, chair of the FED UP! Coalition and president of the Steve Rummler Hope Foundation. Rummler’s son Steve died of a drug overdose in 2011, after becoming addicted to painkillers that were prescribed to him for his chronic back pain.

“The capsules will contain a whopping dose of hydrocodone,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids. Jackson lost his 18-year-old daughter Emily to a single dose of OxyContin in 2006.

“It’s crazy to let this drug go on the market as it undoubtedly will become the next OxyContin that will fuel the opioid addiction epidemic.”

One addiction treatment expert who did not sign the letter says Zohydro will be under such close scrutiny it’s unlikely to be widely abused.

“The opposition to Zohydro is like closing the gate after the horse has left the barn,” said Percy Menzies, president of Assisted Recovery Centers of America, in an email to National Pain Report.

“It is very unlikely that this product will be indiscriminately marketed as happened in the past. Pharmaceutical companies, including the makers of Zyhydro, are going to be extremely cautious about marketing it indiscriminately. The approval is coming at a time of great concern about excessive use of acetaminophen. I do not see Zyhydro or any single entity opioid making things any worse. The FDA has initiated strong strategies like REMS to minimize the abuse of opioid pain medications.”

Zohydro will be classified as a Schedule II drug, which means it can only be dispensed through a physician’s written prescription, with no automatic refills allowed. There are also more stringent recordkeeping, reporting, and security requirements for Schedule II drugs.

So far at least one health insurance company has indicated it is willing to reimburse patients and healthcare providers for Zohydro prescriptions.

In a note to providers about its coverage policy for Zohydro, Humana said it would authorize Zohydro prescriptions for patients who have pain severe enough for daily, around-the-clock opioid treatment; but only if they had already tried at least two other long-acting opioids and found them to be ineffective. The insurer also wants patients to sign pain management agreements with their provider before being prescribed Zohydro.

Authored by: Pat Anson, Editor

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It shouldn’t be surprising that there is such and anti-Zohydro reaction to the introduction of a new more powerful and maybe, just maybe more effective pain relief medicine coming to the market for those of us who suffer interminably with the harrowing scourge of life altering pain. It should also be no surprise that one of the groups wanting to ban this medicine is Kolodny’s PROP (Physicians for Responsible Opioid Prescribing). This group like so many others wanting to ultimately eliminate these medicines for our use are once again taking a position without a great deal of research, let alone, actual use of the medicine.

It’s also disheartening to see a small sentence stating the Zohydro will be easy for recreational and drug addicts to prepare the medicine for snorting and shooting up. Sounds like a reasonable, if hackneyed, accusation against the manufacturing of this and other opioid medicines. But when you peal back that sentence and look closer at it one can already see the same old forces gathering together to blame the pain patient for what ever unhappy outcomes accrue to the use of Zohydro, in other words, just like the opioid “epidemic” the new improved “epidemic” is already gearing up to blame the pain patient for whatever deleterious outcomes that may come to fruition with the use of this new Medicine.

But, as I’ve said before, opioid medicines were developed help reduce the epidemic of pain her in the USA. As sad and horrible it is when anyone becomes ill–addicted–or dies while taking these powerful medicines outside the protective relationship with and experienced provider, that tragedy would not move me at all to try to curtail the availability of these, when used appropriately, medicines. It’s akin to saying that we have over 33,000 deaths yearly due to automobile crashes, therefore we should manufacture fewer cars, restrict the numbers of drivers…well, I imagine you see the point. That same point applies to the a priori banishment of this helpful medicine before it even hits the market.

Yes, sir, PROP, thanks for your scientific contribution to the discussion of Zohydro


I also have chronic pain and am on the highest dose of extended and break through opiates my wonderful, compassionate “pain doctor” can prescribe to a non-terminal patient. My pain keeps increasing but my dose has stayed the same for the last 10 or so years. I am grateful for what I get because without pain medication I would have zero quality of life and honestly don’t think I could have made it this long. If the FDA would only approve opiates with acetaminophen, I would have been dead from liver failure a long time ago! And if you ever have seen a commercial listing the possible fatal diseases like cancer you can get from “off label” use of drugs to treat painful conditions, touting them as “good alternatives” to treat pain like fibro and arthritis you might also be dead or on pain meds anyway to treat your pain from the cancer these non-opiate drugs gave you.

Anyway I am getting off track with the point I want to make. Anyone who truly has chronic pain only wants some relief and to have some “good days” with less pain. Most are careful on how much of any medicines they take. The goal is not to die or abuse medicine that so few doctors are willing to prescribe. Educating and informing both patient and doctor should be mandatory.

I see the REAL OBJECTION is that Zohydro is going to be the pain medicine of choice to prescribe because it is so much safer taken long term by chronic pain patients. Again, it is the acetaminophen combined with the hydrocodone that is the killer especially when taken long term. It seems to be the manufacturers of those medicines that have the most to loose. Sales will drop as chronic pain patients get a stronger, more effective medicine like Zohydro ER that doesn’t damage their liver.

I think that is the real reason they don’t want Zohydro on the market. It always seems to come down to the GREED OF A FEW vrs THE NEED OF MANY!

But this is just my opinion and observation I have come to living on this earth for almost 60 very painful but wonderful years. Thanks, Michele

trudy myers

If any of those people trying to stop the sale of that drug, if they spent one day in my body, they would shut the F up!!
I hurt all the time-24/7 and I take morphine and oxycodone and its not strong enough. If this is on the market-I will beg my doctor for it!!!


I totally agree with u! All this fear! I bet if these opiophobic people had to walk in our shoes or deal with unrelenting pain they might let up already! I’m so tired of people punishing those people who have chronic pain and let them not have access to needed meds. People who are addicts and want to use will find a way! Not everyone who takes opioids/narcotics for chronic pain are addicts or misuse their drugs. What these people need is to be informed and educated! (That includes doctors and health care professionals.)


Let’s punish those who are in chronic pain daily and need pain pills to be able to function. In my case without them I am unable to walk at all. Up until 2 years ago I was a hard working functioning widow with kids. If not my for pain meds my life would be even more destroyed than it already is. Just stop. I am 61 years old and just want to live out what time I have left without pain so bad I feel like I am dying.


If people in pain want to be heard by government regulators they will need to unite- just like woman with breast cancer. Failing that, the dried voices of people in pain will remain mute and meaningless to government regulators whom, I believe see people in pain as a burden.

Ryan Lankford

I’m shocked that a bunch of opiophobes want to limit pain patients’ access to medications that could help their chronic pain. SHOCKED, I TELL YOU!

Hey, a kid could get ahold of a high dose tablet of lisinopril, tank their BP and die. Why isn’t FED UP! campaigning to take blood pressure meds off the market?

These opiophobic prohibitionists make me sick. If you don’t agree with the med, don’t take it. Their agenda is so transparent. How fast will their tunes change when *they* end up with a chronic pain disorder? Will they be content with taking an ibuprofen and sucking it up, or will they demand the type of pain relief they don’t think others sould have the right to obtain?