Zohdryo Sales Begin

Zohdryo Sales Begin

Drug maker Zogenix Inc. (NASDAQ: ZGNX) says its controversial new opioid painkiller Zohydro is now available in “select” pharmacies in the United States, a drug that some addiction treatment experts say could fuel a new wave of narcotic addiction and overdose deaths.

Company officials say their introduction of Zohydro will be “measured, conservative and cautious,” but they eventually plan to market the extended release painkiller to 15,000 physicians who specialize in pain management.

“We have been rather thoughtful, if you will, about focusing on making sure we get to prescribers as soon as we possibly can,” said Zogenix CEO Roger Hawley during a conference call with analysts on the company’s 2013 fourth quarter results.

Zogenix-Zohydro“We’ve taken every measure we could think of that could impact successfully the introduction of this product, as well as minimize its potential for abuse and misuse.”

Zohydro is the first pure hydrocodone painkiller sold in the U.S. Company officials say it will not be marketed directly to consumers and free samples will also not be offered, a common practice when many new drugs are launched.

“We certainly recognize and understand the public health concerns regarding extended released opioid products and our responsibility as a manufacturer to balance patient access with the risk of misuse, abuse, and unintentional overdose of single entity hydrocodone,” said Zogenix President Stephen J. Farr.

The Food and Drug Administration 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.

Last month a coalition of addiction treatment experts, healthcare agencies, and individuals who have lost loved ones to drug overdoses urged the FDA to revoke its approval of Zohydro.

“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.

Several congressmen and the attorneys general from 28 states and the District of Columbia have also asked the FDA to reconsider its decision.

“You’ve all heard it, if you follow our company. There’s a well-orchestrated campaign about the concerns of people who may have strong emotions and bad past experiences about these products,” said Hawley.

“We’re most concerned about some of the inaccurate, incomplete or even misleading information, and quite honestly in my opinion, some fairly inappropriate comments that have been made about the company and our business practices.”

Some of the sharpest criticism of Zogenix has been over its decision to launch Zohydro without an abuse deterrent formula to discourage drug abusers from crushing or liquefying the painkiller so it can be snorted or injected.

The company said it was making “excellent progress” towards developing an abuse deterrent formulation, but it was at least two years away.

“We are making solid progress on two separate projects, with the target of having an approved product by the end of 2016,” said Farr.

One project would add an abuse deterrent to Zohydro capsules. The other formulation would be applied to Zohydro tablets. The drug is currently being sold in capsule form only.

Few benefits and many risks will result from the marketing of Zohydro, according to Richard Blondell, MD, vice chair for addiction medicine at the University at Buffalo.

“We already have a prescription drug problem and the way this drug is packaged makes it easy to abuse. Zohydro is just another opiate product in a market that’s already flooded with them,” said Blondell, a professor of family medicine in the UB School of Medicine and Biomedical Sciences.

“Why introduce a new product that will pose unnecessary risks for those who are already abusing prescription drugs as well as for patients who could become addicted simply by being prescribed these drugs?”

Zogenix recently formed an independent panel of outside experts to monitor the prescribing of Zohydro, as well as any abuse or misuse that may occur. The company is also offering through its website a free locking cap for patients to use on their prescription bottles.

Net loss for Zogenix during the fourth quarter 2013 was $35.6 million, or $0.28 per share, compared to a net loss of $0.6 million, or $0.01 per share, for the fourth quarter 2012. Net loss for the full year 2013 was $80.9 million, or $0.74 per share, compared to a net loss of $47.4 million, or $0.59 per share, for 2012.

Zogenix is not providing financial guidance for 2014. However, the company expects to spend $110 – $120 million on research and development, administrative expenses and sales in 2014. Zogenix has expanded its sales force to 150 sales representatives to help launch Zohydro.

Authored by: Pat Anson, Editor

There are 9 comments for this article
  1. efr at 5:43 am

    A place to begin your search on the fight against Zohydro starts with Sen Manchin (WV). The man has a daughter that is CEO of Mylan who also makes a hydrocodone drug and who’s sales would be affected by Zohydro. So daddy writes a bill for daughter to put the competitor out of business. Icing on the cake, daughters company (Mylan) is the second largest PAC contributor to daddies campaign year in, year out. Zohydro. Missing from article also I believe is any mention that this new wonder pill comes without acetaminophen, a known liver damaging ingredient. Plus it is extended release. Politicians….who exactly are you in the fight for here?

  2. Dennis Kinch at 3:46 pm

    I agree Dave, with everything you are saying, and I’ve seen firsthand the beginnings of this “ideal” treatment around the country. A facility in Phoenix comes to mind as leading the way to the future of pain treatment. They have all the common referral doctors and quite a few alternative docs in one building, including psychotherapy for pain, not depressive syndromes.

    They also have many groups whose patients, headed by a professional, meet once a week for people with Fybro or Lupus, etc. Then once a month they have a “staffing”, where all the professionals and a pain advocate sit and discuss the hard cases and try to troubleshoot a treatment plan. Not the ideal you set up here, but an amazing attempt considering the mind-numbing ignorance and kindergarten approaches to healing being offered, and somehow approved by the medical system.

    We will be in the dark for a long time, unless of course, 100 million people get it together and stand up as one voice and say, “Hey! There’s better things out there and we want them now!”

  3. dave at 11:35 am

    Many people with rare diseases have been cured. The cure may not come in a pill or a surgical procedure and may require considerable searching as well as time and effort.
    I was “cured” of an incurable disease -but the cure didn’t come in the form of a pill or medical intervention. In truth from the start my approach was never on treatment but on ridding myself of disease. Through the grace of God I became disease free-but not after a difficult struggle. Some believe disease can bring you closer to God and make you a better person. Perhaps that is what disease is about.
    With regard to new and improved pills for pain.. seemingly intractable conditions are all the more reason that the focus in health care should be placed not on suboptimal noncurative treatments that force a dependence but on more curative and hopeful care. If a doctor offered me a percocet for osteoarthritis Id say you take it doc- I want more serious care- how about some platelet rich plasma or microwave resonance therapy, some chord blood or actovegin, some LENS or progressive autosanguis therapy, some biopuncture, Motion style acupunture, NES, Chikey, intranasal laser therapy, fa qi or Ling bao bi fa, maybe a 30 day fast or maybe some psychic surgery or help from John of God, Domincic, Mickel, Bengston or a Curandera . But to be on a med indefinately that won’t cure a difficult condition- once again that’s not me.
    And so while I understand the use of painkillers in the short run, in the long run who wants to live with pain and taking painkillers? Not me. It reflects the moral and mental laziness of medicine to be more focused on noncurative pain care then curative pain care- not to mention preventive care.

  4. Dennis Kinch at 1:13 am

    In my case, with a rare disease there is no curative treatments or even a proactive path. My disease causes my bones to degenerate and all they can do is provide pain comfort. So although I agree with you wholeheartedly would I be in a different position, for now, bring on the Zohydro. It may not be help for my case, for all those it would help, I know what you’re going through and I hope it gets to you and provides some relief. Then I hope you use that bit of relief and see if you can start a positive trend in your life.

    Neurontin did this for me and although my condition keeps getting worse, my attitude and belief in myself keep getting better. Pain care is dead in America.. long live “my spirit” care!

  5. dave at 4:11 pm

    New and improved opioids will not do much to improve pain care in the United States. Opioids, like other medications are meant as “treatments” and not as regenerative, rejuvenative or curative care. People seem to miss the point that when companies are spendind time developing treatments for pain and when are tax dollars are spent reviewing and approving treatments- the same time is not spent on finding or approving cures or regenerative care or compounded care. And so for some time now, because both companies and government believe that pain doesnt kill anyone that it isn’t worth the trouble of finding curative treatments like they try for cancers or aids. And so people in pain are damned by the false assumptions and feint dreams of both government and companies in developing suboptimal “treatments”. Though pain specialists talk about changing culture in pain care what they really meant is more of the same old tired approach to pain care in new bottles. Yeah, I know if they had a cure they would market it-but frankly the belief that pain is not serious underlies pain research today- the main focus is on developing treatments that are quick and easy to administer or to make modifications in expensive treatments like surgery. But from my point of view, new medications for pain whether they are venom from spiders or fish or opioids are a big yawn.
    And so I say pain care is dead…long live pain care!

  6. Dennis Kinch at 4:49 pm

    I don’t really get the whole controversy. Zohydro is Hydrocodone, which I took for 2 years when I first began my pain journey in 1992, then got put on vicodin.
    2nd, a study had shown that 1/6 of the patients studied had tried to abuse the drug and the main objection seems to be about abuse. Here again, the abusers, or “bad” people are running the show. Forget the millions and millions of us who are “good”, clean living (in pain) well meaning, honest patients. Forget our numbers or percents.

    Now that it’s OK to get up in arms against a drug because “it might be abused”, lets stop 90% of the OTC drugs being abused by teenagers, or the “nice and pretty” drugs being abused by everyone, like chocolate, sugar substitutes, coffee and soda, fast food….etc. I guess the “fear mongers” have pushed their media attacks to another level and make it sound righteous. And we lose more “adult rights.”
    All I really want to say is…”Fear Mongers! Get the hell out of the argument!! It was chaotic and confusing enough before you added fear into it! You are causing MILLIONS of people more pain. Get out!”

  7. Charity Sheeks at 1:44 pm

    I am so glad they have approved this drug and that it is on it’s way to being in pharmacies!! People living in Chronic pain NEED this so they don’t have to take so much Tylenol in the regular Hydrocodone. I am sure it will be abused (as all medications are) but the benefits FAR outweigh any risk of it being abused!! For those of us suffering daily this is a breath of fresh air! Next problem will be getting the doctor to actual prescribe it to someone.

  8. denise at 10:17 pm

    dave you are right….political hot potato….while im sure zohydro will abused….over prescribed….overused…..and i am sure people will abuse, use, when they are addicts they will lie, steal, pawn stuff just to get thier hands on this “highly controversial” drug. However, the truely pained and chronically pained person are tired of this additute. When you have true, verifiable pain that is chronic (like me i have had it for more than 20yrs.) you get tired of hearing about the addicts…we are judged harshly and treated like we could become an addict at any moment. That makes me sick…I suffer so bad at times that i cant get out of bed for days at a time, i loose weight because i dont eat when im in pain, i always run a fever…not sure why i just do…and by God if i had a chance to take this new stuff i would…but chronic pain sufferers are subject to UA’s at random and they count our pills at every visit or before a procedure. To me that says we dont trust you…..its a standard that is set already….hell cant even get the primary doctor to give u pain meds anymore….they dont want to step on pain managements toes…but pain management has a certain way of doing it…and they have set standards…and god forbid any one that messes up thier way!!!

  9. dave at 5:39 pm

    Talk about a political hot potato!
    The controversy surrounding Zogenix reflects a failure of the democratic process in America. I hope that the outcome is a realization by politicians that we need a more democratic way of making decisions on issues related to pain care for we can no longer afford to keep “the republic” of pain care for it no longer works for people in pain. Pain care is dead in America.. long live pain care!