Drug Maker Seeks to Block Ban on Zohydro

Drug Maker Seeks to Block Ban on Zohydro

San Diego-based Zogenix (NYSE:ZGNX) has filed a lawsuit in federal court in Boston seeking a temporary restraining order to prevent Massachusetts Governor Deval Patrick from implementing a ban on the prescribing and dispensing of Zohydro, the company’s controversial new painkiller.

The suit claims that an executive order issued by Patrick is in “direct conflict” with the authority of the Food and Drug Administration to determine whether a drug is safe and effective. The FDA approved Zohydro – the first pure hydrocodone painkiller — over the objections of its own advisory committee, which warned that Zohydro could be abused even more than currently available hydrocodone products. ZOGENIX, INC. CHARTS, GRAPHSZogenix said a request to meet with the governor to discuss the issue went unanswered.

“Governor Patrick’s unilateral action was taken without any communication or advanced notice. In very limited interactions with his staff after the decision, we are convinced the decision was driven by factual inaccuracies about the science and the data. Unfortunately, it left us little recourse but to put the needs of patients in severe chronic pain ahead of politics and file for an injunction to stop the executive order,” said Roger Hawley, CEO of Zogenix.

“Zohydro was approved by the FDA after an exhaustive 18-month review of the clinical trial data. This rigorous FDA review process serves the nation’s public health needs, the medical community and those in severe chronic pain, and the FDA regulatory authority simply should not be usurped by individual states.”

The FDA is under growing political pressure to reverse its decision. Bills have been introduced in Congress to force the FDA to withdraw its approval of Zohydro.

Update:  Mass Live is reporting that a hearing on the Zogenix lawsuit has been scheduled for Monday, April 14 before U.S. District Court Judge Rya Zobel. Judge Zobel said she is skeptical of Gov. Patrick’s authority to ban a drug that has been approved by the FDA. “At the moment, I think that, frankly, the governor is out of line on this,” Zobel said.

Gov. Patrick declared a public health emergency last month over the “growing opioid addiction epidemic” and ordered the unprecedented ban on Zohydro. Some addiction treatment experts have claimed that Zohydro – which came on the market just a few weeks ago – will fuel a new wave of narcotic abuse and overdoses.

“The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large,” the Governor’s office said in a statement.

Zogenix claims Zohydro is actually safer than other hydrocodone combination products, such as Vicodin, because it does not contain acetaminophen – which can cause liver damage at high doses.

“For those patients in Massachusetts struggling every day with severe chronic pain who are tolerating immediate-release hydrocodone therapies which contain acetaminophen, having a new option of hydrocodone could provide a significant benefit,” the company said. Unlike Vicodin and other hydrocodone products – which require doses every few hours — extended release Zohydro is designed to be taken just twice a day.

Authored by: Pat Anson, Editor

There are 8 comments for this article
  1. Sarah at 12:45 pm

    My mom is trying to get off of all prescription medication, but ironically to do so, she needs a prescription medication. She was on Valium for a pulled muscle that turned out to be a vertebral fracture. She had back surgery and it healed, but the Valium had already sunk its claws into her and she is now experiencing benzodiazepine withdrawal syndrome even after 4 months completely off of the drug. Benzo withdrawal can cause a multitude of horrific symptoms, but her worst one has been extreme muscle pain that causes her to just sob and lay in bed all day when she doesn’t have to work. She barely manages to hold down her job and we have to use every OTC remedy just to patch her together halfway. Without the hydrocodone, I think she would have tried to end her life already. After it takes effect, she’s able to at least get in the shower and take care of her patients at work. But she has to take it multiple times a day and its mixed with acetaminophen, which is totally pointless as she has tried plain acetaminophen and it did NOTHING for her pain, at all. It’s basically just taxing her liver for no reason. The only pain relief she’s getting from these extreme muscle aches is from the hydrocodone, and this syndrome could last for several more months before she’s able to withdraw from the pain medication as well. (We hope). When we heard that Zohydro was coming to market, we were so hopeful because finally a pain medication that won’t be a risk to her liver, that she wouldn’t have to take so often. To hear that there are ignorant people who don’t experience crippling pain themselves trying to block it from people in legitimate need just INFURIATES ME!!! People who want to abuse a substance will find a way to do so, and the mistakes of self-destructive people should not be basis for denying pain relief to those who suffer through every waking moment in some sort of horrific pain. I am so tired of this nanny state that doesn’t allow responsible adults to make decisions about their own bodies. I just really hope that this medication will be available soon despite the smear campaign. Nearly every article I see about the controversy over Zohydro is full of comments from people who are desperate for pain relief minus the harmful/pointless acetaminophen.

  2. Myron Shank, M.D., Ph.D. at 7:09 pm

    Paradoxically, the opposition to the legitimate use of extended release hydrocodone risks increasing its abuse.

  3. Pauly at 12:35 pm

    Good for you! There is nothing wrong with Zohydro. Who does the governor of Mass think he is anyway?????? He’s not a doctor. Who gave him any prescribing or rather non-prescribing power ???? Again I say WHO DOES HE THINK HE IS ??????????

  4. Steve M at 10:17 pm

    Aside from his decision being based on propaganda, not solid medical evidence, this ban doesn’t just apply to Zohydro. Every patient who had compounded hydrocodone before this is now forced to switch to toxic acetaminophen combination products or stronger opioids, lime oxycodone or hydromorphone.

  5. dave at 5:41 pm

    There are two bills in Congress-http://thomas.loc.gov/cgi-bin/bdquery/z?d113:HR04241:@@@P to ban Zohydro-and I think the Massachussetts legislature has a bill to ban Zohydro- A federal court heard the manufacturer of Zohydro today and the Mass Governor on lifting the ban on Zohydro-and they will be back in court next week.
    High drama for a pain treatment-and the controversy over Zohydro may have repercussions for access to other opioids, as well.

  6. David B at 5:36 am

    The biggest stakeholders in Zohydro- people in pain should be the ones to decide by referendum the fate of Zohydro. This is another example, where big brother wishes to decide for us what we can and cant have without our advice or consent. Pain care today is about politics and profits and not about people in pain.

  7. Christina at 7:34 pm

    This is why politics do not belong in health decisions. If someone wants to abuse something you are NOT going to stop them. Forcing chronic pain patients limit optitions is hurt legitiment patients. When is someone going to fight for us and ban politics from making decisions that effect patients? The WAR ON DRUGS is really a war on pain patients. We our treated like criminal and profiled the moment we walk up to the pharmacy counter. Herion is back on the streets at full swing and killing people. because they don’t know how much to do or because it was cut with something bad. Good job politicians!! Chronic pain is never going to stop.

  8. Trudy McGee at 7:21 pm

    The nightmare begins….and where will it end??? With the repeal of all opiods?