Click here to close now.

SYS-CON MEDIA Authors: Yeshim Deniz, Pat Romanski, Carmen Gonzalez, Liz McMillan, Roger Strukhoff

News Feed Item

Zogenix Statement: Let's Get the Facts Straight About Zohydro ER

SAN DIEGO, April 2, 2014 /PRNewswire/ -- We are extremely disappointed that the U.S. Drug Enforcement Administration (DEA) Administrator, as she did in a Congressional hearing today, would repeat misinformation about Zohydro™ ER that has been demonstrated to be false.

As informed health care experts and the U.S. Food and Drug Administration have noted for the record, Zohydro ER is no more potent than any other hydrocodone medication available.

The facts are clear: Zohydro ER is the same hydrocodone currently available in a number of combination products, but without acetaminophen. In fact, in terms of hydrocodone potency, a 10 mg dose of Zohydro ER is actually the exact same potency as a 10 mg dose of Vicodin or any other hydrocodone product. There are also many marketed opioids that are more potent than hydrocodone such as oxymorphone, methadone, hydromorphone and fentanyl.

In terms of maximum strength in a single pill, all other extended-release opioids have a higher dosage strength than Zohydro ER. For example, the highest dosage unit of extended-release oxycodone is 80 mg and the highest dosage unit of extended-release morphine is 200 mg, both of which are substantially higher than the highest dosage unit of Zohydro ER (which ranges from 10 mg to 50 mg).

Zohydro ER is the only acetaminophen-free hydrocodone pain reliever available for long-term, daily, severe chronic pain patients who are obtaining relief with short-acting hydrocodone combination products, but who are at risk for potentially fatal liver toxicity due to their daily intake of acetaminophen.

Like our nation's leaders, we are committed to the safe and appropriate use of prescription medications. Zogenix has taken extraordinary steps to support the appropriate use of Zohydro ER through a voluntary, comprehensive set of educational tools and safeguards to augment the FDA industry mandated class-wide Risk Evaluation Mitigation Strategy (REMS) for extended-release opioids.

As part of our continued efforts to provide additional safeguards against the potential diversion, overdose and misuse of Zohydro ER, Zogenix has established an External Safe Use Board of experts. Zogenix is also compensating our product representatives not on sales volume of Zohydro ER, but rather on their efforts to ensure prescribers, pharmacists and patients are educated to understand the risks and benefits of using extended-release opioids. Finally, Zogenix provides patients who are prescribed Zohydro ER access to free locking pill bottle caps and discounted safe-storage units to prevent others in the home from obtaining easy access to medicine that was not prescribed for them.

On behalf of those who suffer with severe chronic pain, we will continue to move aggressively to correct false and misleading statements about Zohydro ER. The plight of people living with severe chronic pain is too important to treat otherwise. 

About Zohydro ER

INDICATION

Zohydro™ ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated 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.

LIMITATIONS OF USE

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Zohydro ER is not indicated for use as an as‑needed (prn) analgesic.

Please see the Zohydro ER full prescribing information for the complete boxed warning and safety information.

WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME and INTERACTION WITH ALCOHOL

  • Zohydro ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor regularly for development of these behaviors or conditions.
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow Zohydro ER whole to avoid exposure to a potentially fatal dose of hydrocodone.
  • Accidental consumption of Zohydro ER, especially in children, can result in fatal overdose of hydrocodone.
  • For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome. Prolonged use during pregnancy can result in life-threatening neonatal opioid withdrawal syndrome.
  • Instruct patients not to consume alcohol or any products containing alcohol while taking Zohydro ER because co-ingestion can result in fatal plasma hydrocodone levels.

IMPORTANT SAFETY INFORMATION

Zohydro ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma or hypercarbia; known or suspected paralytic ileus; and hypersensitivity to hydrocodone bitartrate or any other ingredients in Zohydro ER.

Zohydro ER contains hydrocodone, a Schedule II controlled substance. As an opioid, Zohydro ER exposes users to the risks of addiction, abuse, and misuse. As modified-release products, such as Zohydro ER, deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.

Potential serious adverse events caused by opioids include respiratory depression, potential for misuse and abuse, CNS depressant effects, prolonged gastric obstruction, and severe hypotension. The most common adverse reactions associated with Zohydro ER ( ≥ 2%) include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, peripheral edema, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain and tremor.

Zohydro ER uses Alkermes Pharma Ireland Limited's patented Spheroidal Oral Drug Absorption System (SODAS®) drug delivery technology, which serves to enhance the release profile of hydrocodone to provide extended-release pain relief relative to existing immediate-release combination products.

For more information about Zohydro ER, please visit: www.ZohydroEr.com or the Zohydro ER REMS website at www.ZohydroERREMS.com.

About Zogenix

Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with pain-related conditions and central nervous system disorders who need innovative treatment alternatives to help them return to normal daily functioning. The Company has commercialized two products using technology to enhance the patient experience and has a development pipeline that includes a once-monthly subcutaneous injection for schizophrenia. More information about Zogenix is available at www.zogenix.com

ZohydroTM ER is a trademark of Zogenix, Inc.

SOURCE Zogenix, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading in...
All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades. With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo, June 9-11, 2015, at the Javits Center in New York City. Learn what is going on, contribute to the discussions, and ensure that your enter...
SYS-CON Events announced today that EnterpriseDB (EDB), the leading worldwide provider of enterprise-class Postgres products and database compatibility solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. EDB is the largest provider of Postgres software and services that provides enterprise-class performance and scalability and the open source freedom to divert budget from more costly traditiona...
In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.
An entirely new security model is needed for the Internet of Things, or is it? Can we save some old and tested controls for this new and different environment? In his session at @ThingsExpo, New York's at the Javits Center, Davi Ottenheimer, EMC Senior Director of Trust, reviewed hands-on lessons with IoT devices and reveal a new risk balance you might not expect. Davi Ottenheimer, EMC Senior Director of Trust, has more than nineteen years' experience managing global security operations and asse...
The Internet of Things is a misnomer. That implies that everything is on the Internet, and that simply should not be - especially for things that are blurring the line between medical devices that stimulate like a pacemaker and quantified self-sensors like a pedometer or pulse tracker. The mesh of things that we manage must be segmented into zones of trust for sensing data, transmitting data, receiving command and control administrative changes, and peer-to-peer mesh messaging. In his session a...
Organizations today are confounded by an avalanche of data that needs to be processed and managed on a daily basis. Through relevant use cases and a thought-provoking dialogue on an organization’s ‘Data to Decisions’ journey, Andrew Clyne, Chief Data Officer at CenturyLink Cognilytics, will reveal in his session at Big Data Expo how your organization can monetize data as a strategic asset. State-of-the-art Big Data and Advanced Analytics capabilities provided as a managed service can enable da...
There is no doubt that Big Data is here and getting bigger every day. Building a Big Data infrastructure today is no easy task. There are an enormous number of choices for database engines and technologies. To make things even more challenging, requirements are getting more sophisticated, and the standard paradigm of supporting historical analytics queries is often just one facet of what is needed. As Big Data growth continues, organizations are demanding real-time access to data, allowing immed...
SYS-CON Events announced today that the "First Containers & Microservices Conference" will take place June 9-11, 2015, at the Javits Center in New York City. The “Second Containers & Microservices Conference” will take place November 3-5, 2015, at Santa Clara Convention Center, Santa Clara, CA. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
There is no question that the cloud is where businesses want to host data. Until recently hypervisor virtualization was the most widely used method in cloud computing. Recently virtual containers have been gaining in popularity, and for good reason. In the debate between virtual machines and containers, the latter have been seen as the new kid on the block – and like other emerging technology have had some initial shortcomings. However, the container space has evolved drastically since coming on...
With worldwide spending on cloud services and infrastructure growing by 23% in 2015 to $118B, it is clear that cloud services are here to stay. Yet, the rate of cloud adoption varies by companies and markets around the world. With thousands of outages and hijacks across the Internet every day, one reason for hesitation is the faith in quality Internet performance. In his session at 16th Cloud Expo, Michael Kane, Senior Manager at Dyn, will explore how Internet performance affects your end-user...
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? In this Power Panel at DevOps Summit, moderated by Jason Bloomberg, the leading expert on architecting agility for the enterprise and president of Intellyx, panelists will peel away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud en...
While great strides have been made relative to the video aspects of remote collaboration, audio technology has basically stagnated. Typically all audio is mixed to a single monaural stream and emanates from a single point, such as a speakerphone or a speaker associated with a video monitor. This leads to confusion and lack of understanding among participants especially regarding who is actually speaking. Spatial teleconferencing introduces the concept of acoustic spatial separation between confe...
We are all here because we are sold on the transformative promise of The Cloud. But what good is all of this ephemeral, on-demand infrastructure if your usage doesn't actually improve the agility and speed of your business? How must Operations adapt in order to avoid stifling your Cloud initiative? In his session at DevOps Summit, Damon Edwards, co-founder and managing partner of the DTO Solutions, will highlight the successful organizational, process, and tooling patterns of high-performing c...
Data-intensive companies that strive to gain insights from data using Big Data analytics tools can gain tremendous competitive advantage by deploying data-centric storage. Organizations generate large volumes of data, the vast majority of which is unstructured. As the volume and velocity of this unstructured data increases, the costs, risks and usability challenges associated with managing the unstructured data (regardless of file type, size or device) increases simultaneously, including end-to-...