one state bans....next? is the ship sinking?

The proof will be in the outcome, sugar pants! Hydrocodone is written because it is a CIII, CIIs take a bit more admin time for providers to fill. As you may know, Self Proclaimed Einstien, hydrocodone is also the single most abused opioid. I'm done with you, you're too smart for little ol' me?

 

It's all over but the crying..... Best you can do is black boxed. Docs and patients have to sign waiver. Good luck.

 

Zogenix Takes Legal Action in Federal Court to Block Massachusetts Improper Ban

Zogenix Takes Legal Action in Federal Court to Block Massachusetts Improper Ban on Zohydro™ ER

Company Files for Injunction - Prescription Drug Status Should Reside Solely With the FDA


SAN DIEGO, April 7, 2014 /PRNewswire/ -- Zogenix, Inc. (Nasdaq: ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today filed a lawsuit in the U.S. District Court in Massachusetts requesting the court to grant a temporary restraining order against execution of the executive order recently announced by Governor Deval Patrick, which prohibits the prescribing and dispensing of the Company's prescription pain product that was approved by the U.S. Food and Drug Administration (FDA). Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, is the first and only extended-release hydrocodone without acetaminophen for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The suit argues that this decision is in direct conflict with the authority of the FDA to determine on behalf of the public whether a drug is safe and effective, and to impose the measures necessary to ensure that the drug will be used safely and appropriately.

The legal action comes after a formal written request to the Governor for a meeting to discuss the facts about the product went unanswered. 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 at the same daily dose currently being prescribed and taken 4 – 6 times per day and reduce their risk to overdose of acetaminophen.

"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, chief executive officer of Zogenix. "Zohydro ER 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."

Zogenix Commitment to Ensuring Appropriate Use

Zogenix has taken extraordinary steps to ensure its medicine is used safely and prescribed according to the recently revised label required by the FDA for all extended release/long acting (ER/LA) opioid analgesics. In addition, Zogenix is also participating with the NDA sponsors of other ER/LA opioids in the design and conduct of post-marketing required studies to assess the potential for serious risks associated with long-term use of these medications.

Zohydro ER is the only hydrocodone product on the market today that is subject to a Risk Evaluation and Mitigation Strategy (REMS) specifically developed by the FDA to minimize the risk of abuse of long acting opioid drugs, and is the only hydrocodone product currently subject to Schedule II controls by the Drug Enforcement Administration. These requirements make Zohydro ER the most comprehensively regulated hydrocodone product on the market today, with more safeguards against misuse, abuse and diversion than any other hydrocodone-based product.

Extensive education is provided to patients and prescribers on the proper use of Zohydro ER by Zogenix to ensure they fully understand the risks associated with the use of extended release opioids. Zogenix has also implemented a broad and vigorous surveillance system under the oversight of an external safe use board to detect for signals of abuse, misuse and diversion in order to take immediate corrective actions, which began prior to the product becoming available on the market.

 

game on. Mass will lose this.

 

I wonder if Zogenics will decide to battle the entire country as each state falls in line to block Zohydro use. Poor timing in light of pre-existing growing concerns about misuse, abuse, and diversion. It may work to reduce pain but the liability is too great at this stage.

 

The scientific case for a selective ban against Zohydro is a fantasy. They will fight, and they will win. (They have no other choice.) If anyone really cares about safety, then Roxicodone, generic oxymorphone ER, and Exalgo should also be banned. No one is screaming for that. Wonder why.

 

This is quickly becoming the stupidest most asinine argument I have ever heard. Physicians have more important things to do - like actually treat patients - rather than throw backlash againt this drug. If they do not like it or think it is dangerous to the patient, simply do not write it!!!! Jesus Christ,,,, really??? This is just another case of physicians having to deal with another powerful drug, if they educated themselves properly and used this only for the ones who truly need it, rather than writing haphazerdly, there would be no issue. The issue here isn't the power of the drug, its the physicians fear of them carelessly writing for the wrong patient, and then having to face the consiquences of their poor judgement in treatment options. I have been a rep for a long time, and I see how physicians 'think' they know everything, they would rather complain and throw out personall issues with a drug rather than get fully educated on it and understand that this IS a drug that could help some people - they just need to understand which patient type it is best for, monitor them properly and closely, and just don't write for it if they don't think it's best for the patient. My God, do they really have to be told this???? Heres a news flash, this drug, and this company is here to stay, at least for a while. I could see this company being bought out, but not in the short term.

 

judge overrules Zohydro ban in Mass. Just in case the brain trust didn't notice.

 

You Pumpkin Heads are going to try and do what better reps with better products couldn't? NuCynta ER, Opana ER, Avinza, Kadian, Exalgo mostly launched from companies with extensive histories in pain market. They squeaked by at BEST! LA morphine, Duragesic, and OxyContin occupy that market. Enjoy your crumbs

 

Take a look at OxyContin sales. Going in the wrong direction. The new formulation doesn't have the pop of the old one, and you have to have a throat the size of a horse's to swallow it. The qualities that engendered high brand loyalty (and a solid formulary position) no longer exist. Even if Zohydro didn't exist, you'd be toast. OC days are numbered.

 

You think a product that the FDA mandated...ie. they told the industry Acetaminophen was on it's way out.... i going to flail?

The simple fact that this is VICODIN without TYLENOL for any idiots who don't know that, is what will make this drug a hit. The state made it out like it's pure heroin or something. Yet how many of us have vicodin in our medicine cabinet from a root canal? It is the same damn thing without tylenol. Simple.

GO ZGNX!